FDA Medical Device Recalls (openFDA)
Maquet Inc: Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, Sweden.
- Recall number
- Z-0571-05
- Recalling firm
- Maquet Inc
- Product
- Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, Sweden.
- Status
- Terminated
- Initiated
- 2005-01-03
- Posted
- 2005-03-08
- Terminated
- 2005-09-08
- Reason
- Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.
- Root cause
- Other
- Action
- Customer letter mailed on January 3, 2005 via certified postage, with return self-addressed postcards that customers must complete to acknowledge receipt of the instructions to refer to their Service and Operating Manuals.
- Quantity
- 7920 units
- Distribution
- The ventilators were distributed to hospitals nationwide. There are 33 VA Medical Center and DOD hospitals nationwide.
- Lot, serial or model codes
- All units with the Serial Numbers 24578 and lower. Total of 7920 units.
- 510(k) numbers
- ["K902859","K970839"]
- 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