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

FDA device recall Z-1203-2007 · posted 2007-09-07 · Terminated

Recall details

Recalling firm

MAQUET Inc.

Reason for recall

Overcharging of batteries and the release of acid fumes

Action taken

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

Status

Terminated

Product code

BSZ

Quantity affected

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

Date initiated

2007-07-10

Date posted

2007-09-07

Date terminated

2007-12-07

Location

Bridgewater, NJ