Z-1203-2007
Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden
Maquet Cardiovascular Us Sales, LLC / initiated 2007-07-10 / Terminated
MAQUET Inc. began a recall of Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden on . The reason FDA records is "Overcharging of batteries and the release of acid fumes". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1203-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Maquet Cardiovascular Us Sales, LLC
- Product
- Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden
- Product code
- BSZ Gas-Machine, Anesthesia
- Reason for recall
- Overcharging of batteries and the release of acid fumes
- FDA 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 in commerce
- 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
- Product codes and lots
- Article number 6454800 and 6462910 Serial # 1719, 2034, 3078, 3416, 3417, 3418, 3419, 3420, 3027.
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