FDA Medical Device Recalls (openFDA)
Respironics California Inc: Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics
- Recall number
- Z-0903-04
- Recalling firm
- Respironics California Inc
- Product
- Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics
- Status
- Terminated
- Initiated
- 2001-06-01
- Posted
- 2004-07-20
- Terminated
- 2004-05-12
- Reason
- Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue.
- Root cause
- Other
- Action
- Firm technicians and foreign representatives were responsible for updating software on or about 6/1/01.
- Quantity
- 749
- Distribution
- Nationwide, Argentina, Brazil, Canada, China, Chile, Egypt, India, Italy, Japan, Korea, Mexico, Pakistan, Panama, Philipines, Puerto Rico, Singapore, Spain, Thailand, Turkey, Vietnam.
- Lot, serial or model codes
- All Codes.
- 510(k) numbers
- ["K981072"]
- 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