Siemens AXIOM Artis zeego x-ray, angiographic system
FDA Recall Z-1945-2013 · Posted 2013-08-09
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2013-05-13
Date Terminated2014-11-06
Product Quantity132
Reason for Recall
Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system.
Firm Action
The firm, Siemens, sent an "Important safety notice" by letter on May 13, 2013 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to immediately notify the service department to clarify what further measures need to be taken, if after carrying out the regular brake test, the system can only be moved at a reduced speed. If this device has been sold and is therefore no longer in your possession, send this safety notice to the new owner and provide the new owner to Siemens.
Update instruction AX012/13/S was issued, and a software update will be released as AX006/13/S and AX007/13/S which will modify the system software so that it will not be possible for information to be overlaid.
If you have any questions call +49 (9191) 18 0.
Root Cause
Software design
Distribution Pattern
Nationwide distribution: AL, AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MD, MN, MO,MS, NC, NE, NH, NJ, NY, OH, PA, PR, SD, TN, TX, UT, VA, WA, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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