| 2026-05-29 |
Class I
|
Ongoing |
Z-2463-2026 |
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 … |
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Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will… |
| 2026-05-22 |
Class II
|
Ongoing |
Z-2625-2026 |
IntelliCuff, Portable automatic cuff pressure controller REF: 951001 |
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Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the … |
| 2025-06-26 |
Class I
|
Ongoing |
Z-2167-2025 |
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, H… |
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Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory a… |
| 2025-06-03 |
Class I
|
Ongoing |
Z-2328-2025 |
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended t… |
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A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (n… |
| 2024-05-15 |
Class I
|
Ongoing |
Z-2020-2024 |
Ventilator HAMILTON-C6, PN: 160021 |
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Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User p… |
| 2023-07-26 |
Class I
|
Ongoing |
Z-2530-2023 |
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator |
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Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or… |
| 2023-07-26 |
Class I
|
Ongoing |
Z-2529-2023 |
Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator |
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Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or… |
| 2023-07-26 |
Class I
|
Ongoing |
Z-2528-2023 |
Hamilton-MR1, REF: 161010, Intensive Care Ventilator |
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Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or… |
| 2023-07-26 |
Class I
|
Ongoing |
Z-2527-2023 |
Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator |
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Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or… |
| 2023-07-26 |
Class I
|
Ongoing |
Z-2526-2023 |
Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator |
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Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or… |
| 2023-07-26 |
Class I
|
Ongoing |
Z-2525-2023 |
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator |
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Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or… |
| 2023-06-15 |
Class I
|
Ongoing |
Z-2142-2023 |
HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatr… |
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Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. |
| 2023-06-15 |
Class I
|
Ongoing |
Z-2141-2023 |
HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and opt… |
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Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. |
| 2023-06-15 |
Class I
|
Ongoing |
Z-2140-2023 |
HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory sup… |
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Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. |
| 2023-06-15 |
Class I
|
Ongoing |
Z-2139-2023 |
HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults a… |
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Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. |
| 2023-03-14 |
Class II
|
Ongoing |
Z-1429-2023 |
HAMILTON-C6, REF: 160021 |
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Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not m… |
| 2022-09-22 |
Class II
|
Ongoing |
Z-0267-2023 |
Hamilton-C6 |
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Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the … |
| 2022-06-27 |
Class I
|
Ongoing |
Z-1525-2022 |
HAMILTON-C6 Intensive Care Ventilator, REF: 160021 |
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Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault alarms. Multiple technica… |
| 2021-01-05 |
Class III
|
Completed |
Z-1385-2022 |
HAMILTON-H900 Humidifier, Models: 950001, 950004 |
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When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water i… |