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Recall Observatory FDA recall evidence

Device 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

Z-1958-2015

May 05, 2015

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 71270
Status
Terminated
Classification
Class II
Quantity
37
Official record key
device-enforcement:Z-1958-2015

Official wording

Reason: under certain circumstances the Cios Alpha system may freeze during a procedure.

Code information: Model Number of device 10308191, serial numbers: 11032 11044 11005 10115 11056 10057 10076 10019 10021 10035 10037 10073 11074 11075 11077 11083 10078 11066 11067 11013 10063 10082 11094 10089 11080 11009 11018 11082 10058 10098 11015 11016 11038 10096 10116 11035 11064

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    under certain circumstances the Cios Alpha system may freeze during a procedure.