Facility
PULSION MEDICAL SYSTEMS SE
1 recall(s) on record — most severe on record: Class I.
| FDA Establishment Identifier (FEI) | 3003263092 |
|---|---|
| Establishment type | Manufacture Medical Device |
| Location | Einstein Ring 30 Aschheim, DE 85609 |
| Registration status | Active · expires 2026 |
| Parent company | Maquet Critical Care AB (owner-operator 9036213) |
| Brand names | ITS Housing |
Devices registered here (1)
- Probe, ThermodilutionProduct code KRB · Class II · Cardiovascular · 21 CFR 870.1915
Recalls & enforcement
- Class IOngoing2025-05-30Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →
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