Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: 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
FDA Recall Z-1295-2019 · Posted None
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2019-03-22
Date Terminated2020-05-12
Product Quantity2 US
Reason for Recall
Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists
Firm Action
Siemens issued Customer Safety Advisory Letter dated 3/22/19 advising of problem, health risk and action to take: recommends to avoid overwriting the organ programs, as this can lead to frequent operations. Siemens is distributing this letter and the addendum to the user manual to all potentially affected users Contact our service organization for any additional questions at 1-800-888-7436.
Root Cause
Device Design
Distribution Pattern
US Nationwide Distribution in the states of NC, MA
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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