Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 8/26/2015
Class lI:
PRODUCT
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Recall Number Z-2404-2015
REASON
in case a system error occurs and the system enters the “Bypass Fluoro” mode while the X-ray locking function is active, the only way to exit the X-ray locking function, would be to either resolve the root cause of the system being in “Bypass Fluoro” or to restart the system..
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 6/30/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
986
DISTRIBUTION
Nationwide
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