FDA Medical Device Recalls (openFDA)
Event Medical: INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200000-XX, F7300000-XX; where XX designates the language variant. IN = English (International); GB=English (US); FR= French; DE=German; IT=Italian; PT=Portuguese; ES=Spanish; JP=Japanese; PL=Polish; RU=Russian
- Recall number
- Z-0062-06
- Recalling firm
- Event Medical
- Product
- INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200000-XX, F7300000-XX; where XX designates the language variant. IN = English (International); GB=English (US); FR= French; DE=German; IT=Italian; PT=Portuguese; ES=Spanish; JP=Japanese; PL=Polish; RU=Russian
- Status
- Terminated
- Initiated
- 2005-08-12
- Posted
- 2005-10-15
- Terminated
- 2012-02-29
- Reason
- Firm received reports of combustion within the blender system of the Inspiration Ventilator.
- Root cause
- Other
- Action
- Customer shall be notified by an Urgent Product Safety Notfication letter dated August 12, 2005. The letter shall advise the customer with the specifics of this problem, summarise the fact that the hazard potential in negligible and will advise the customer regarding options for replacement of the Blender Module assembly (part number F710400) and the Air/O2 Filters (part number F910300). The letter will also provide the customers with a set of actions which can be completed immediately in order to ensure the integrity of their gas supplies until their unit has been upgraded.
- Quantity
- 1,602 units
- Distribution
- Nationwide and Canada, Europe, Japan, Latin America, Asia/Pacific, Middle East
- Lot, serial or model codes
- All serial numbers for Models F7100000-XX, F7200000-XX, and F7300000-XX
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3006135941
- Firm city
- Vista
- Firm state
- CA
- 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