PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
This recall has been terminated (originally issued August 14, 2015).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- July 13, 2015
- Posted
- August 14, 2015
- Terminated
- March 1, 2017
- Recall Number
- Z-2343-2015
- Quantity
- 2081
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution.
Lot / Code Info
Catalog Number(s): 8416400, 8417400
Root Cause
Nonconforming Material/Component
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.
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