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Terminated

Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden

FDA Recall Z-1203-2007 · Posted 2007-09-07

Recalling FirmMAQUET Inc.
Recall StatusTerminated
Product CodeBSZ
Date Initiated2007-07-10
Date Terminated2007-12-07
Product Quantity9 units in US

Reason for Recall

Overcharging of batteries and the release of acid fumes

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide: 2 units at the National Institute of Health in Bethesda, MD and 7 units at Oconee Regional Medical Center, Milledgeville, GA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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