GE HEALTHCARE FINLAND OY — FDA Facility Profile
GE HEALTHCARE FINLAND OY is an FDA-registered facility (FEI 3002806783) located in HELSINKI Uusimaa, FI. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Feb 2, 2012: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (1 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 5, latest Sep 26, 2025
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 2, 2012 | Voluntary Action Indicated (VAI) | Design validation - user needs and intended uses (21 CFR 820.30(g)) |
| Jan 29, 2009 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Sep 26, 2025 | Class II | Z-0453-2026 | Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or… and 4 more products Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge… |
| Apr 5, 2024 | Class II | Z-2168-2024 | CARESCAPE Canvas 1000, Model Numbers:
a) 5865770;
b) 5865770-01040169… and 4 more products GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain… |
| May 19, 2023 | Class I | Z-2026-2023 | TruSignal Adult/Pediatric Sensor; Oximeter, Ear:
a) REF TS-AP-10, 10 pcs;
b) REF… and 8 more products There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate… |
| Sep 4, 2018 | Class II | Z-0095-2019 | GE Healthcare CARESCAPE Monitor B450
Product Usage: Intended uses of CARESCAPE B450 in… and 1 more product When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the… |
| May 25, 2018 | Class II | Z-2340-2018 | GE Healthcare CARESCAPE Monitor B650 When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the… |
Facility details
- Company
- GE Healthcare Finland Oy
- Location
- HELSINKI Uusimaa (FI)
- Source
- device