FDA Medical Device Recalls (openFDA)
Respironics California Inc: Esprit Ventilator
- Recall number
- Z-1230-04
- Recalling firm
- Respironics California Inc
- Product
- Esprit Ventilator
- Status
- Terminated
- Initiated
- 2002-02-20
- Posted
- 2004-07-28
- Terminated
- 2004-12-02
- Reason
- Flow sensors would exhibit drift.
- Root cause
- Other
- Action
- Oxygen flow sensors were replaced in all ventilators by service technicians in the USA. Parts were given to foreign consignees. Recall is complete.
- Quantity
- 907
- Distribution
- Nationwide, Australia, Argentina, Brazil, Canada, Chile, Colombia, Spain, Germany, Hong Kong, India, Italy, Japan, Korea, Mexico, Malaysia, Panama, Philipines, Pakistan, Puerto Rico, Singapore, Thailand, Turkey, Taiwan, Venezuela Vietnam
- Lot, serial or model codes
- Too numerous to include.
- 510(k) numbers
- ["K023350","K034040","K981072","K001208"]
- PMA numbers
- not on file
- Product code
- CBK
- 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