MAQUET CRITICAL CARE AB — FDA Facility Profile
MAQUET CRITICAL CARE AB is an FDA-registered facility (FEI 3002808128) located in SOLNA Stockholm, SE. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Sep 26, 2019: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (1 OAI, 1 VAI)
- Last OAI inspection
- Sep 13, 2013
- 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
- 3, latest Jun 30, 2026
- Import refusals
- 5
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Sep 26, 2019 | Voluntary Action Indicated (VAI) | Lack of or inadequate DHR procedures (21 CFR 820.184) Product rework procedures, Lack of or inadequate procedures (21 CFR 820.90(b)(2)) Lack of or inadequate process validation (21 CFR 820.75(a)) Individual Report of Malfunction (21 CFR 803.50(a)(2)) |
| Sep 13, 2013 | Official Action Indicated (OAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jun 30, 2026 | Not yet classified | Z-2963-2026 | GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N… The module did not undergo electrical safety tests and functional tests during production. |
| Jun 24, 2026 | Not yet classified | Z-2860-2026 | Flow Anesthesia Machine
Flow-i C20 6677200
Flow-i C30 6677300
Flow-i C40… Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may… |
| May 30, 2025 | Not yet classified | Z-2013-2025 | Servo-u Ventilator System. Model Number: 6688600. and 2 more products Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect… |
Facility details
- Company
- Maquet Critical Care AB
- Location
- SOLNA Stockholm (SE)
- Source
- device