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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Z-0455-2026 - B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102 6160000-103 6160000-104 6160000-105 6160001-063 6160001-064 6160... 2 11/07/2025 FEI # 3002806783
GE Healthcare Finland Oy
Z-0457-2026 - BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S 2 11/07/2025 FEI # 3002806783
GE Healthcare Finland Oy
Z-0454-2026 - CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms... 2 11/07/2025 FEI # 3002806783
GE Healthcare Finland Oy
Z-0453-2026 - Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms R... 2 11/07/2025 FEI # 3002806783
GE Healthcare Finland Oy
Z-0456-2026 - Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms 2 11/07/2025 FEI # 3002806783
GE Healthcare Finland Oy
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