| 2026-03-02 |
Class I
|
Ongoing |
Z-1649-2026 |
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device. |
— |
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. |
| 2026-03-02 |
Class I
|
Ongoing |
Z-1648-2026 |
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device. |
— |
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. |
| 2026-03-02 |
Class I
|
Ongoing |
Z-1647-2026 |
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device. |
— |
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. |
| 2026-03-02 |
Class I
|
Ongoing |
Z-1646-2026 |
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. |
— |
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. |
| 2026-03-02 |
Class I
|
Ongoing |
Z-1617-2026 |
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device. |
— |
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by t… |
| 2026-03-02 |
Class I
|
Ongoing |
Z-1616-2026 |
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device. |
— |
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by t… |
| 2026-03-02 |
Class I
|
Ongoing |
Z-1615-2026 |
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device. |
— |
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by t… |
| 2026-03-02 |
Class I
|
Ongoing |
Z-1614-2026 |
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. |
— |
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by t… |
| 2025-10-07 |
Class II
|
Ongoing |
Z-0481-2026 |
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for th… |
— |
Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage ou… |
| 2025-06-30 |
Class I
|
Ongoing |
Z-2229-2025 |
DreamStation Auto. Non-Continuous Ventilator. |
— |
Devices may possess a programming error resulting in an incorrect device configuration. |
| 2025-06-30 |
Class I
|
Ongoing |
Z-2228-2025 |
DreamStation Auto BiPAP. Non-Continuous Ventilator. |
— |
Devices may possess a programming error resulting in an incorrect device configuration. |
| 2025-06-30 |
Class I
|
Ongoing |
Z-2227-2025 |
DreamStation Auto CPAP. Non-Continuous Ventilator. |
— |
Devices may possess a programming error resulting in an incorrect device configuration. |
| 2025-05-09 |
Class I
|
Ongoing |
Z-2037-2025 |
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric pa… |
— |
This device does not indicate for use in patients with respiratory failure. |
| 2025-05-09 |
Class I
|
Ongoing |
Z-2036-2025 |
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more… |
— |
This device does not indicate for use in patients with respiratory failure. |
| 2025-05-09 |
Class I
|
Ongoing |
Z-2035-2025 |
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighin… |
— |
This device does not indicate for use in patients with respiratory failure. |
| 2024-10-07 |
Class I
|
Ongoing |
Z-0296-2025 |
LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult … |
— |
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could l… |
| 2024-10-07 |
Class I
|
Ongoing |
Z-0295-2025 |
Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult pa… |
— |
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could l… |
| 2024-10-07 |
Class I
|
Ongoing |
Z-0294-2025 |
Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult pat… |
— |
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could l… |
| 2024-10-07 |
Class I
|
Ongoing |
Z-0293-2025 |
Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200… |
— |
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could l… |
| 2024-10-07 |
Class I
|
Ongoing |
Z-0292-2025 |
Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediat… |
— |
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could l… |
| 2024-10-07 |
Class I
|
Ongoing |
Z-0291-2025 |
Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110… |
— |
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could l… |
| 2024-10-07 |
Class I
|
Ongoing |
Z-0290-2025 |
Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100… |
— |
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could l… |
| 2024-07-16 |
Class I
|
Ongoing |
Z-2944-2024 |
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2… |
— |
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identi… |
| 2024-07-16 |
Class I
|
Ongoing |
Z-2943-2024 |
Trilogy Evo Universal Ventilator, Model No. DS2000X11B |
— |
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identi… |
| 2024-07-16 |
Class I
|
Ongoing |
Z-2942-2024 |
Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy E… |
— |
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identi… |
| 2024-04-01 |
Class I
|
Ongoing |
Z-1817-2024 |
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 11111… |
— |
Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, … |
| 2024-03-26 |
Class I
|
Ongoing |
Z-1814-2024 |
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 11… |
— |
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxem… |
| 2024-03-26 |
Class I
|
Ongoing |
Z-1813-2024 |
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 11111… |
— |
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxem… |
| 2024-03-26 |
Class I
|
Ongoing |
Z-1812-2024 |
BiPAP V30 Auto Ventilator, Part Number 1111178 |
— |
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxem… |
| 2024-03-19 |
Class I
|
Ongoing |
Z-1505-2024 |
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. |
— |
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| 2024-03-19 |
Class I
|
Ongoing |
Z-1504-2024 |
Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. |
— |
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| 2024-03-19 |
Class I
|
Ongoing |
Z-1503-2024 |
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. |
— |
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| 2024-03-19 |
Class I
|
Ongoing |
Z-1502-2024 |
Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. |
— |
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| 2024-03-19 |
Class I
|
Ongoing |
Z-1501-2024 |
LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US) |
— |
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| 2024-03-19 |
Class I
|
Ongoing |
Z-1500-2024 |
Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US) |
— |
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| 2024-03-19 |
Class I
|
Ongoing |
Z-1499-2024 |
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US) |
— |
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| 2023-11-27 |
Class II
|
Ongoing |
Z-0638-2024 |
Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B … |
— |
The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. Th… |
| 2023-08-25 |
Class I
|
Ongoing |
Z-2631-2023 |
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) … |
— |
Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function. |
| 2023-05-25 |
Class II
|
Ongoing |
Z-2106-2023 |
Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use |
— |
There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive". |
| 2023-05-01 |
Class I
|
Ongoing |
Z-1652-2023 |
Trilogy Evo Universal Ventilator, Model Number DS2000X11B |
— |
The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventil… |
| 2023-05-01 |
Class I
|
Ongoing |
Z-1651-2023 |
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, … |
— |
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flo… |
| 2023-05-01 |
Class I
|
Ongoing |
Z-1650-2023 |
Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, F… |
— |
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flo… |
| 2023-05-01 |
Class I
|
Ongoing |
Z-1649-2023 |
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110… |
— |
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flo… |
| 2023-03-01 |
Class I
|
Ongoing |
Z-1289-2023 |
Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B |
— |
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if… |
| 2023-03-01 |
Class I
|
Ongoing |
Z-1288-2023 |
Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR… |
— |
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if… |
| 2023-03-01 |
Class I
|
Ongoing |
Z-1287-2023 |
Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15… |
— |
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if… |
| 2023-02-10 |
Class I
|
Ongoing |
Z-1322-2023 |
Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, U… |
— |
A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Sh… |
| 2022-12-07 |
Class I
|
Ongoing |
Z-0884-2023 |
Philips Garbin Ventilator, Model Number 1058180B |
— |
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attac… |
| 2022-12-07 |
Class I
|
Ongoing |
Z-0883-2023 |
Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, … |
— |
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attac… |
| 2022-12-07 |
Class I
|
Ongoing |
Z-0882-2023 |
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 10… |
— |
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attac… |
| 2022-12-07 |
Class I
|
Ongoing |
Z-0882-2023 |
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 10… |
— |
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attac… |
| 2022-09-06 |
Class I
|
Ongoing |
Z-1784-2022 |
Therapy Mask 3100 NC/SP |
— |
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. |
| 2022-09-06 |
Class I
|
Ongoing |
Z-1783-2022 |
Wisp and Wisp Youth Nasal Mask |
— |
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. |
| 2022-09-06 |
Class I
|
Ongoing |
Z-1782-2022 |
DreamWisp Nasal Mask with Over the Nose Cushion |
— |
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. |
| 2022-09-06 |
Class I
|
Ongoing |
Z-1781-2022 |
Philips Respironics DreamWear Full Face Mask |
— |
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. |
| 2022-09-06 |
Class I
|
Ongoing |
Z-1780-2022 |
Philips Respironics Amara View Minimal Contact Full-Face Mask |
— |
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. |
| 2022-08-26 |
Class I
|
Ongoing |
Z-1659-2022 |
Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patient… |
— |
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| 2022-08-26 |
Class I
|
Ongoing |
Z-1658-2022 |
Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstru… |
— |
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| 2022-08-26 |
Class I
|
Ongoing |
Z-1657-2022 |
Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apne… |
— |
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| 2022-08-26 |
Class I
|
Ongoing |
Z-1656-2022 |
Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea s… |
— |
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| 2022-08-26 |
Class I
|
Ongoing |
Z-1655-2022 |
Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndro… |
— |
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| 2022-08-26 |
Class I
|
Ongoing |
Z-1654-2022 |
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndro… |
— |
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| 2021-12-22 |
Class I
|
Ongoing |
Z-0494-2022 |
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides … |
— |
Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based poly… |
| 2021-12-22 |
Class I
|
Ongoing |
Z-0493-2022 |
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous … |
— |
Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based poly… |
| 2021-07-26 |
Class II
|
Ongoing |
Z-2290-2021 |
Trilogy Evo Universal, Product number DS2000X11B |
— |
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure … |
| 2021-07-26 |
Class II
|
Ongoing |
Z-2289-2021 |
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B |
— |
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure … |
| 2021-07-26 |
Class II
|
Ongoing |
Z-2288-2021 |
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA21… |
— |
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure … |
| 2021-07-26 |
Class II
|
Ongoing |
Z-2287-2021 |
Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X… |
— |
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure … |
| 2021-06-14 |
Class I
|
Ongoing |
Z-1974-2021 |
SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators … |
— |
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, a… |
| 2021-06-14 |
Class I
|
Ongoing |
Z-1973-2021 |
DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Contin… |
— |
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, a… |
| 2021-06-14 |
Class I
|
Ongoing |
Z-1972-2021 |
Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbe… |
— |
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, a… |
| 2021-06-14 |
Class I
|
Ongoing |
Z-1958-2021 |
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting |
— |
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and th… |
| 2021-06-14 |
Class I
|
Ongoing |
Z-1957-2021 |
A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Suppo… |
— |
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and th… |
| 2021-06-14 |
Class I
|
Ongoing |
Z-1956-2021 |
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators. |
— |
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and th… |
| 2021-04-06 |
Class II
|
Terminated |
Z-1630-2021 |
BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169 |
— |
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile… |
| 2021-04-06 |
Class II
|
Terminated |
Z-1629-2021 |
BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143 |
— |
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile… |
| 2021-04-06 |
Class II
|
Terminated |
Z-1628-2021 |
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177 |
— |
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile… |
| 2021-04-06 |
Class II
|
Terminated |
Z-1627-2021 |
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177 |
— |
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile… |
| 2021-04-06 |
Class II
|
Terminated |
Z-1626-2021 |
BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169 |
— |
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile… |
| 2021-04-06 |
Class II
|
Terminated |
Z-1625-2021 |
BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178 |
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Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile… |