fda
17 records
FDA Recall: GE Healthcare Finland Oy — Class II
20251119
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide | Product: B105P, B125P, B105M, B125M, B155M Pati...
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FDA Device Recall: B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 61600
2025-11-19
Class II — Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occur...
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FDA Device Recall: CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteri
2025-11-19
Class II — Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occur...
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FDA Device Recall: Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With
2025-11-19
Class II — Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occur...
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FDA Device Recall: BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors
2025-11-19
Class II — Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occur...
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FDA Device Recall: CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 58
2024-07-03
Class II — GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 mo...
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FDA Device Recall: CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAE
2024-07-03
Class II — GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 mo...
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FDA Device Recall: CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2)
2024-07-03
Class II — GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 mo...
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FDA Device Recall: CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2
2024-07-03
Class II — GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 mo...
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FDA Device Recall: TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
2023-07-12
Class I — There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
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FDA Device Recall: TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oxi
2023-07-12
Class I — There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
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FDA Device Recall: TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
2023-07-12
Class I — There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
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FDA Device Recall: TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, phy
2023-07-12
Class I — There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
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FDA Recall: GE Healthcare Finland Oy — Class II
20180711
When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simu | Product: GE Healthcare CARESCAPE Monitor B650
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FDA Device Recall: GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCA
2018-10-17
Class II — When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. ...
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FDA Device Recall: GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARES
2018-10-17
Class II — When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. ...
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FDA Device Recall: GE Healthcare CARESCAPE Monitor B650
2018-07-11
Class II — When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The mo...
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