FDA Medical Device Recalls (openFDA)
MAQUET Inc.: Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care
- Recall number
- Z-0372-2007
- Recalling firm
- MAQUET Inc.
- Product
- Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care
- Status
- Terminated
- Initiated
- 2006-05-23
- Posted
- 2007-01-25
- Terminated
- 2008-04-11
- Reason
- Reported failures of the SERVO-i ventilators user interface system causing technical errors and increased fault frequencies. Switches may be activated unintentionally, or a function not activate when the switch is selected. Direct access knobs may not function or change the parameter in the wrong direction compared to how they are turned.
- Root cause
- Other
- Action
- Maquet sent an ''Extended Warranty'' letter on May 23, 2006. On March 13, 2007, Maquet issued a Recall Notification letter to all customers stating that they will replace all PC1777 boards in the serial number range 2400-3300, which have not previously been replaced. A safety alert letter was included outlining the failure indication and effect for the user of the failures, as well as, how to identify whether the Servo-i unit has shown any failure indications.
- Quantity
- 1, 970 units
- Distribution
- Worldwide
- Lot, serial or model codes
- Article # 64-87-800 Serial numbers 02400 - 03300
- 510(k) numbers
- ["K010925"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3008355164
- Firm city
- 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