Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 7/8/2015
Class lI:
PRODUCT
Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients
Recall Number Z-1958-2015
REASON
Under certain circumstances the Cios Alpha system may freeze during a procedure.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 5/5/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
37
DISTRIBUTION
Nationwide
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