GE Healthcare Finland Oy

Complete recall history across all FDA and CPSC categories — 22 total recalls

GE Healthcare Finland Oy appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (22)

FDA medical device enforcement actions by GE Healthcare Finland Oy

Date Product Reason Class
Sep 26, 2025 Carescape B450, Model no. 5805686 - shipped with potentially affected batteri... Potential loss of monitoring on affected monitors when powered by certain bat... Class II
Sep 26, 2025 B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 61... Potential loss of monitoring on affected monitors when powered by certain bat... Class II
Sep 26, 2025 BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monito... Potential loss of monitoring on affected monitors when powered by certain bat... Class II
Sep 26, 2025 Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (Wit... Potential loss of monitoring on affected monitors when powered by certain bat... Class II
Sep 26, 2025 CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batt... Potential loss of monitoring on affected monitors when powered by certain bat... Class II
Apr 5, 2024 CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, ... GE HealthCare has become aware of the potential for loss of monitoring on CAR... Class II
Apr 5, 2024 CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001,... GE HealthCare has become aware of the potential for loss of monitoring on CAR... Class II
Apr 5, 2024 CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, ... GE HealthCare has become aware of the potential for loss of monitoring on CAR... Class II
Apr 5, 2024 CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c)... GE HealthCare has become aware of the potential for loss of monitoring on CAR... Class II
Apr 5, 2024 CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / ... GE HealthCare has become aware of the potential for loss of monitoring on CAR... Class II
May 19, 2023 TruSignal Ear Sensor, REF TS-E-D; Oximeter There is a potential reduction of energy reaching patient during defibrillati... Class I
May 19, 2023 TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear There is a potential reduction of energy reaching patient during defibrillati... Class I
May 19, 2023 TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter There is a potential reduction of energy reaching patient during defibrillati... Class I
May 19, 2023 TruSignal Wrap Sensor, REF TS-W-D; Oximeter There is a potential reduction of energy reaching patient during defibrillati... Class I
May 19, 2023 TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs;... There is a potential reduction of energy reaching patient during defibrillati... Class I
May 19, 2023 TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, ... There is a potential reduction of energy reaching patient during defibrillati... Class I
May 19, 2023 TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter There is a potential reduction of energy reaching patient during defibrillati... Class I
May 19, 2023 TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; ... There is a potential reduction of energy reaching patient during defibrillati... Class I
May 19, 2023 TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter There is a potential reduction of energy reaching patient during defibrillati... Class I
Sep 4, 2018 GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CA... When multiple CARESCAPEMonitor B450 or B850 units are connected to the same n... Class II
Sep 4, 2018 GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARE... When multiple CARESCAPEMonitor B450 or B850 units are connected to the same n... Class II
May 25, 2018 GE Healthcare CARESCAPE Monitor B650 When multiple CARESCAPE Monitor B650 units are connected to the same network ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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