FDA Medical Device Recalls (openFDA)
Draeger Medical, Inc.: PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
- Recall number
- Z-2343-2015
- Recalling firm
- Draeger Medical, Inc.
- Product
- PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
- Status
- Terminated
- Initiated
- 2015-07-13
- Posted
- 2015-08-14
- Terminated
- 2017-03-01
- 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.
- Lot, serial or model codes
- Catalog Number(s): 8416400, 8417400
- 510(k) numbers
- ["K093632","K093633"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2517967
- Firm city
- Telford
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28