PlainRecalls
FDA Devices Moderate Class II Terminated

Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.

Reported: February 12, 2014 Initiated: November 15, 2013 #Z-0907-2014

Product Description

Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.

Reason for Recall

During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.

Details

Units Affected
147
Distribution
Nationwide Distribution.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 147.
Why was this product recalled?
During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 12, 2014. Severity: Moderate. Recall number: Z-0907-2014.