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U.S. Department of Health and Human Services

Class 2 Device Recall Kion Anesthesia Workstation

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 Class 2 Recall
Kion Anesthesia Workstation
see related information
Date Posted September 07, 2007
Recall Status1 Terminated on December 07, 2007
Recall Number Z-1203-2007
Recall Event ID 38428
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
Product Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden
Code Information Article number 6454800 and 6462910 Serial # 1719, 2034, 3078, 3416, 3417, 3418, 3419, 3420, 3027.
Recalling Firm/
Manufacturer
MAQUET Inc.
1140 US Highway 22
Bridgewater, New Jersey 08807-2958
For Additional Information Contact Jamie Yieh
908-947-2311
Manufacturer Reason
for Recall
Overcharging of batteries and the release of acid fumes
FDA Determined
Cause 2
TRAINING: Employee Error
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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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