FDA Medical Device Recalls (openFDA)
Draeger Medical, Inc.: Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
- Recall number
- Z-0827-2016
- Recalling firm
- Draeger Medical, Inc.
- Product
- Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
- Status
- Terminated
- Initiated
- 2016-02-04
- Posted
- 2016-02-25
- Terminated
- 2020-04-01
- Reason
- The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.
- Root cause
- Software design
- Action
- Draeger Medical, Inc. will send an Urgent Medical Device Recall Letter to consignees in a method that confirms delivery. For consignees that have received new devices with firmware version 1.50 (127 devices) or through device updates (644 devices; reference Recall Z-0436-2016), those devices will be downgraded to firmware version 1.49 and the batteries replaced. Batteries will continue to be replaced for all consignees every six months until a final solution is available.
- Quantity
- 2553
- Distribution
- US Nationwide Distribution including Puerto Rico.
- Lot, serial or model codes
- Catalog #s 8416400 and 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