| 2025-09-26 |
Class II
|
Ongoing |
Z-0457-2026 |
BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Pa… |
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Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up p… |
| 2025-09-26 |
Class II
|
Ongoing |
Z-0456-2026 |
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms |
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Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up p… |
| 2025-09-26 |
Class II
|
Ongoing |
Z-0455-2026 |
B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-1… |
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Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up p… |
| 2025-09-26 |
Class II
|
Ongoing |
Z-0454-2026 |
CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a … |
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Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up p… |
| 2025-09-26 |
Class II
|
Ongoing |
Z-0453-2026 |
Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spa… |
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Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up p… |
| 2024-04-05 |
Class II
|
Ongoing |
Z-2172-2024 |
CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 20786… |
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GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCA… |
| 2024-04-05 |
Class II
|
Ongoing |
Z-2171-2024 |
CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-… |
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GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCA… |
| 2024-04-05 |
Class II
|
Ongoing |
Z-2170-2024 |
CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01… |
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GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCA… |
| 2024-04-05 |
Class II
|
Ongoing |
Z-2169-2024 |
CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, p… |
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GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCA… |
| 2024-04-05 |
Class II
|
Ongoing |
Z-2168-2024 |
CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e… |
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GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCA… |
| 2023-05-19 |
Class I
|
Ongoing |
Z-2034-2023 |
TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter |
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There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 |
Class I
|
Ongoing |
Z-2033-2023 |
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter |
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There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 |
Class I
|
Ongoing |
Z-2032-2023 |
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia dete… |
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There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 |
Class I
|
Ongoing |
Z-2031-2023 |
TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear |
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There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 |
Class I
|
Ongoing |
Z-2030-2023 |
TruSignal Ear Sensor, REF TS-E-D; Oximeter |
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There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 |
Class I
|
Ongoing |
Z-2029-2023 |
TruSignal Wrap Sensor, REF TS-W-D; Oximeter |
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There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 |
Class I
|
Ongoing |
Z-2028-2023 |
TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter |
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There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 |
Class I
|
Ongoing |
Z-2027-2023 |
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter |
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There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 |
Class I
|
Ongoing |
Z-2026-2023 |
TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs |
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There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |