Recall Z-1203-2007 ยท BSZ Gas-Machine, Anesthesia
MAQUET Inc.
Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden
| Date | Sep 7, 2007 (initiated Jul 10, 2007) |
| Status | Terminated |
| 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 b |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.