FDA Medical Device Recalls (openFDA)
Respironics California Inc: ESPRIT VENTILATOR, Model V1000
- Recall number
- Z-0951-03
- Recalling firm
- Respironics California Inc
- Product
- ESPRIT VENTILATOR, Model V1000
- Status
- Terminated
- Initiated
- 2001-06-08
- Posted
- 2003-07-01
- Terminated
- 2004-05-11
- Reason
- Material hardness on original design check valve may cause premature failure.
- Root cause
- Other
- Action
- Firm plans to replace all of the check valves in the field. Recall was communicated by issuance of a Field Communication 2001-25 dated 8 June 2001.
- Quantity
- 749
- Distribution
- Throughout the US and to Vietnam,Turkey, Thailand, Spain, Singapore, Puerto Rico, Philipines, Peru, Panama, Pakistan, Mexico, Malaysia, Korea, Japan, Italy, Indonesia, Egypt, Columbia, China, Canada, Brazil, Argentina.
- Lot, serial or model codes
- All Codes.
- 510(k) numbers
- ["K981072"]
- PMA numbers
- not on file
- Product code
- CPK
- Firm FEI
- 2518422
- Firm city
- Carlsbad
- 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