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GE Healthcare Finland Oy FDA Recalls
19 recalls on file across devices, 9 of them Class I and 19 still open. Matched by name to GEHC.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-1Class IISep 26, 2025Potential loss of monitoring on affected monitors when power |
| Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spaClass IISep 26, 2025Potential loss of monitoring on affected monitors when power |
| BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer PaClass IISep 26, 2025Potential loss of monitoring on affected monitors when power |
| Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or AlarmsClass IISep 26, 2025Potential loss of monitoring on affected monitors when power |
| CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a Class IISep 26, 2025Potential loss of monitoring on affected monitors when power |
| CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01Class IIApr 5, 2024GE HealthCare has become aware of the potential for loss of |
| CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; eClass IIApr 5, 2024GE HealthCare has become aware of the potential for loss of |
| CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 20786Class IIApr 5, 2024GE HealthCare has become aware of the potential for loss of |
| CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-Class IIApr 5, 2024GE HealthCare has become aware of the potential for loss of |
| CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, pClass IIApr 5, 2024GE HealthCare has become aware of the potential for loss of |
| TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; OximeterClass IMay 19, 2023There is a potential reduction of energy reaching patient du |
| TruSignal Sensitive Skin Sensor, REF TS-SE-3; OximeterClass IMay 19, 2023There is a potential reduction of energy reaching patient du |
| TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; OximeterClass IMay 19, 2023There is a potential reduction of energy reaching patient du |
| TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, EarClass IMay 19, 2023There is a potential reduction of energy reaching patient du |
| TruSignal Ear Sensor, REF TS-E-D; OximeterClass IMay 19, 2023There is a potential reduction of energy reaching patient du |
| TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcsClass IMay 19, 2023There is a potential reduction of energy reaching patient du |
| TruSignal Wrap Sensor, REF TS-W-D; OximeterClass IMay 19, 2023There is a potential reduction of energy reaching patient du |
| TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; OximeterClass IMay 19, 2023There is a potential reduction of energy reaching patient du |
| TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia deteClass IMay 19, 2023There is a potential reduction of energy reaching patient du |