Atlas FDA

GE Healthcare Finland Oy

19 FDA 510(k) clearances · Recalling firm

Sort:Newest firstOldest first

◉ Watch GE Healthcare Finland Oy

RecordFirmDate
Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affecte recall (Z-0453-2026)GE Healthcare Finland Oy2025-11-07
CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affe recall (Z-0454-2026)GE Healthcare Finland Oy2025-11-07
B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 616 recall (Z-0455-2026)GE Healthcare Finland Oy2025-11-07
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detec recall (Z-0456-2026)GE Healthcare Finland Oy2025-11-07
BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 20 recall (Z-0457-2026)GE Healthcare Finland Oy2025-11-07
CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142 recall (Z-2168-2024)GE Healthcare Finland Oy2024-06-21
CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; recall (Z-2169-2024)GE Healthcare Finland Oy2024-06-21
CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418- recall (Z-2170-2024)GE Healthcare Finland Oy2024-06-21
CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01 recall (Z-2171-2024)GE Healthcare Finland Oy2024-06-21
CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) recall (Z-2172-2024)GE Healthcare Finland Oy2024-06-21
TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, recall (Z-2026-2023)GE Healthcare Finland Oy2023-07-07
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter recall (Z-2027-2023)GE Healthcare Finland Oy2023-07-07
TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter recall (Z-2028-2023)GE Healthcare Finland Oy2023-07-07
TruSignal Wrap Sensor, REF TS-W-D; Oximeter recall (Z-2029-2023)GE Healthcare Finland Oy2023-07-07
TruSignal Ear Sensor, REF TS-E-D; Oximeter recall (Z-2030-2023)GE Healthcare Finland Oy2023-07-07
TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear recall (Z-2031-2023)GE Healthcare Finland Oy2023-07-07
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological recall (Z-2032-2023)GE Healthcare Finland Oy2023-07-07
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter recall (Z-2033-2023)GE Healthcare Finland Oy2023-07-07
TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter recall (Z-2034-2023)GE Healthcare Finland Oy2023-07-07

Track GE Healthcare Finland Oy automatically

Every clearance here is in the API, with alerts when new ones post.