—#172036

Product

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 product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K181560
Affected lot / code info: Cios Alpha system with SW VA30

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide Distribution in the states of NC, MA

Timeline

Recall initiated: 2019-03-22
Terminated: 2020-05-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172036. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.