FDA Medical Device Recalls (openFDA)
Maquet Inc: Servo-i Ventilator
- Recall number
- Z-0878-05
- Recalling firm
- Maquet Inc
- Product
- Servo-i Ventilator
- Status
- Terminated
- Initiated
- 2005-03-24
- Posted
- 2005-06-08
- Terminated
- 2005-09-08
- Reason
- Complaints about batteries indicating a satisfying remaining time but after a short time suddenly shut off without giving alarms to indicate short remaining battery back-up time. (Power off alarm will be given).
- Root cause
- Other
- Action
- Maquet sent out a Safety alert Letter on 3/31/2005 to all users of the Servo-i.
- Quantity
- 4379 units
- Distribution
- The ventilators were distributed nationwide to hosptials and clinics.
- Lot, serial or model codes
- All Servo-i units with serial numbers below 17617.
- 510(k) numbers
- ["K040221"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3008355164
- Firm city
- East Bridgewater
- Firm state
- NJ
- 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