FDA Medical Device Recalls (openFDA)
Maquet Inc: KION Anesthesia System.
- Recall number
- Z-0710-05
- Recalling firm
- Maquet Inc
- Product
- KION Anesthesia System.
- Status
- Terminated
- Initiated
- 2005-01-11
- Posted
- 2005-04-14
- Terminated
- 2005-06-16
- Reason
- Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality.
- Root cause
- Other
- Action
- MCC has assigned an internal task team to manage plan and perform the correction ofthe installed base of KION (intended for clinical use) in US. Updates started on January 11, 2005.
- Quantity
- 40
- Distribution
- The systems were distributed to hospitals throughout the nation.
- Lot, serial or model codes
- Serial Number: 2034; 3416; 3417; 3418; 3419; 3420; 3027; 0501; 3394; 3395; 3396; 3433; 3444; 3445; 3446; 2355; 2356; 2033; 2035; 1838; 1839; 1840; 1841; 1842; 1873; 1874; 1875; 1876; 1877; 1899; 1900; 1902; 1903; 2132; 2032; 1723; 1724; 1725; 1726; 1727.
- 510(k) numbers
- ["K024213"]
- PMA numbers
- not on file
- Product code
- BZR
- 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