PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: May 15, 2019 Initiated: March 22, 2019 #Z-1295-2019

Product Description

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

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

Details

Units Affected
2 US
Distribution
US Nationwide Distribution in the states of NC, MA
Location
Malvern, PA

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 2 US.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 15, 2019. Severity: Moderate. Recall number: Z-1295-2019.

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