FDA Medical Device Recalls (openFDA)
MAQUET Inc.: Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden
- Recall number
- Z-1203-2007
- Recalling firm
- MAQUET Inc.
- Product
- Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden
- Status
- Terminated
- Initiated
- 2007-07-10
- Posted
- 2007-09-07
- Terminated
- 2007-12-07
- Reason
- Overcharging of batteries and the release of acid fumes
- Root cause
- Other
- Action
- Safety Alert letters were sent out by FedEx tracking. A Service Express letter will be sent out emphasizing that only qualified batteries must be used in KION equipment and will list all qualified battery types. A Field Action - update of existing operating manuals will include warning on battery charging on KION. This action is currently scheduled to start 9/1/07 and be completed in US by 10/1/07. After FDA consultation the recalling firm issued a 9/5/2007 URGENT DEVICE CORRECTION Letter stating that KION will visit consignees and replace batteries older than three years, verify that the batteries are ones of the approved type, and verify battery condition.
- Quantity
- 9 units in US
- Distribution
- Nationwide: 2 units at the National Institute of Health in Bethesda, MD and 7 units at Oconee Regional Medical Center, Milledgeville, GA
- Lot, serial or model codes
- Article number 6454800 and 6462910 Serial # 1719, 2034, 3078, 3416, 3417, 3418, 3419, 3420, 3027.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSZ
- 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