Manufacturer

GE Healthcare Finland Oy

22 recalls in our database name GE Healthcare Finland Oy as the manufacturing or recalling firm.

What the numbers show

Total: 22
Critical: 0
Severe: 9
Most recent: 2025-11-19

Of the 22 recalls from GE Healthcare Finland Oy we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (41%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–22 of 22

HighFDA (Devices)·Z-0453-2026·2025-11-19
Patient monitors recalled over batteries that can lose backup power
GE Healthcare is recalling 3,271 Carescape B450 patient monitors because certain batteries can lose the ability to hold charge, causing a loss of patient monitoring.
Product
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 Record updated 3/19/26 to include: CARESCAPE B450 MBA313 2095800-001 CARESCAPE M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0455-2026·2025-11-19
Bedside patient monitors recalled over batteries that fail as backup power
GE Healthcare is recalling 7,408 B105P, B125P, B105M, B125M and B155M patient monitors because certain batteries can lose the ability to hold charge, causing a loss of monitoring.
Product
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 6160001-065 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms 3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0454-2026·2025-11-19
CARESCAPE ONE monitors recalled over batteries that fail to hold charge
GE Healthcare is recalling 5,935 CARESCAPE ONE patient monitors because certain batteries can lose the ability to hold charge, causing a loss of patient monitoring.
Product
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 Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0457-2026·2025-11-19
Monitor batteries recalled because they can lose the ability to charge
GE Healthcare is recalling 2,857 FLEX-3S2P lithium-ion batteries used with patient monitors because they can lose the capability to hold charge and provide backup power.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0456-2026·2025-11-19
Portrait vital signs monitors recalled over batteries losing backup power
GE Healthcare is recalling 5,990 Portrait VSM patient monitors because certain batteries can lose the ability to hold charge, causing a loss of patient monitoring.
Product
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2168-2024·2024-07-03
GE CARESCAPE Canvas monitors may lose display following power loss events
GE Healthcare medical monitors may fail to display following a power loss event after CPU battery replacement, potentially delaying patient condition recognition.
Product
CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865770-01054698; f) 5865770-01054721; g) 5865770-01054740; h) 5865770-01055202; i) 5865770-01055204; j) 5865770-01055270; k) 5865770-01055317; l) 5865
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2170-2024·2024-07-03
Patient Monitors May Fail to Display Vitals After Power Loss
GE Healthcare is recalling certain CARESCAPE Canvas patient monitors that may fail to display vital signs after a power loss if the CPU battery has been replaced. This could delay recognition of changes in patient condition.
Product
CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317, f) 5514418-01086007, g) 5514418-01086838, h) 5514418-01088182, i) 5514418-01108442, j) 5514418-01118673, k) 5514418-01120764
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2169-2024·2024-07-03
GE CARESCAPE Canvas Smart Display monitors may fail to restart after power loss
GE CARESCAPE Canvas Smart Display monitors may fail to turn on after a power loss, particularly following battery replacement, potentially delaying recognition of patient condition changes.
Product
CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2172-2024·2024-07-03
CARESCAPE Patient Monitors May Not Power On After Battery Replacement
Certain GE CARESCAPE patient monitors may fail to power on after mains power loss during battery maintenance, potentially delaying recognition of patient condition changes.
Product
CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 2078633-017, 5) 2078633-028, 6) 2095802-001-54069330, 7) 2095802-001-554922, 8) 2095802-001-554923, 9) 2095802-001-554924, 10) 2095802-001-554925, 11) 2095802
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2171-2024·2024-07-03
GE CARESCAPE Monitors May Fail to Power On After Battery Replacement
GE Healthcare recalls CARESCAPE B650 patient monitors that may fail to power on after mains power loss following CPU timekeeper battery replacement, potentially delaying recognition of patient condition changes.
Product
CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-01023150, 4) 2095801-001-01023151, 5) 2095801-001-01023152, 6) 2095801-001-01032962, 7) 2095801-001-01033915, 8) 2095801-001-01034302, 9) 2095801-001-0103
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2032-2023·2023-07-12
GE TruSignal Ear Sensor recalled for defibrillation, voltage, and measurement risks
GE Healthcare is recalling 2,707 TruSignal Integrated Ear Sensors (GTIN 00840682103428) worldwide due to potential reduced defibrillation energy delivery, unintended voltage exposure, and inaccurate measurements.
Product
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2030-2023·2023-07-12
GE TruSignal Ear Sensor oximeter recalled for electrical and measurement hazards
GE Healthcare is recalling approximately 10,451 TruSignal Ear Sensor oximeters worldwide due to potential electrical hazards and inaccurate measurements that could affect patient safety.
Product
TruSignal Ear Sensor, REF TS-E-D; Oximeter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2029-2023·2023-07-12
TruSignal Wrap Sensor Oximeter Recalled for Defibrillation Failure
GE Healthcare is recalling 5,039 TruSignal Wrap Sensor oximeters due to potential defibrillation energy loss, electrical shock risk, and inaccurate measurements. No illnesses have been reported.
Product
TruSignal Wrap Sensor, REF TS-W-D; Oximeter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2028-2023·2023-07-12
FDA Recalls GE Healthcare Oximeter Sensors for Defibrillation and Electrical Hazards
GE Healthcare is recalling 2,097 TruSignal Sensitive Skin Sensor oximeters worldwide due to risks of reduced defibrillation energy, unintended electrical contact, and inaccurate measurements.
Product
TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2027-2023·2023-07-12
FDA Recalls TruSignal AllFit Oximeter Sensors Worldwide for Device Malfunction
GE Healthcare is recalling 36,337 TruSignal AllFit Sensor oximeters worldwide due to potential defibrillation energy loss, voltage exposure, and measurement errors.
Product
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2034-2023·2023-07-12
Medical Oximeter Sensor Recalled Due to Defibrillation Energy and Voltage Hazards
GE Healthcare is recalling 237 TruSignal Integrated Ear Sensors worldwide due to potential failures in defibrillation energy delivery, unintended voltage contact, and measurement inaccuracy.
Product
TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2026-2023·2023-07-12
TruSignal adult and pediatric ear oximeter sensors recalled for voltage hazards
GE Healthcare's TruSignal Adult/Pediatric ear oximeter sensors are recalled worldwide due to potential reduction of defibrillation energy, risk of unintended electrical contact, and inaccurate oxygen measurement.
Product
TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2033-2023·2023-07-12
GE TruSignal Ear Sensor Oximeter Recalled for Defibrillation Energy and Voltage Hazards
GE Healthcare is recalling 708 TruSignal Integrated Ear Sensors (medical-grade pulse oximeters) due to potential defects that could reduce defibrillation energy, cause electrical shock, or produce inaccurate measurements.
Product
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2031-2023·2023-07-12
Ear oximeter sensor recalled for defibrillation and voltage safety concerns
GE Healthcare is recalling 512 TruSignal ear oximeter sensors worldwide due to potential defibrillation energy loss, unintended voltage exposure, and measurement inaccuracy risks.
Product
TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0095-2019·2018-10-17
GE Healthcare CARESCAPE Monitor B450 Recalled for Network-Related Restart Issues
GE Healthcare is recalling CARESCAPE Monitor B450 units because they may restart simultaneously and fail to complete the process if connected to an overloaded network.
Product
GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthc
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0096-2019·2018-10-17
GE Healthcare CARESCAPE Monitor B850 Recalled for Network-Related Restart Issues
GE Healthcare is recalling CARESCAPE Monitor B850 units because they may simultaneously restart during prolonged network overload, preventing the restart from completing until the network issue is corrected.
Product
GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facili
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2340-2018·2018-07-11
GE Healthcare CARESCAPE Monitor B650 Recalled for Network Overload Restart Issues
GE Healthcare is recalling 69,231 CARESCAPE Monitor B650 units worldwide because they may simultaneously restart during prolonged network overloads.
Product
GE Healthcare CARESCAPE Monitor B650
Category
Medical Device
Distribution
0 states