PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and n
FDA device recall Z-2343-2015 · posted 2015-08-14 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
- Action taken
- Draeger Medical, Inc. sent an Urgent Medical Device Recall Letter, dated July 2015, to end users to inform them of the issue and provide interim instructions to avoid the associated risk to patients. All PS500 batteries will be exchanged free of charge.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 2081
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-07-13
- Date posted
- 2015-08-14
- Date terminated
- 2017-03-01
- Location
- Telford, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE (K093632) | Drager Medical AG & Co. Kgaa | 2010-04-05 |
| INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE (K093633) | Draegerwerk AG & CO Kgaa | 2010-03-30 |