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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 Device Recall Kion Anesthesia Workstation see related information
Date Initiated by Firm July 10, 2007
Date Posted September 07, 2007
Recall Status1 Terminated 3 on December 07, 2007
Recall Number Z-1203-2007
Recall Event ID 38428
Product Classification Anesthesia Workstation - 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 NJ 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		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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