Recall Z-2343-2015 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical, Inc.
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
| Date | Aug 14, 2015 (initiated Jul 13, 2015) |
| Status | Terminated |
| Reason | The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 2081 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |