PlainRecalls
FDA Devices Moderate Class II Terminated

SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

Reported: October 14, 2015 Initiated: August 14, 2015 #Z-0021-2016

Product Description

SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

Reason for Recall

software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin

Details

Units Affected
113 total
Distribution
Nationwide Distribution.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 113 total.
Why was this product recalled?
software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin
Which agency issued this recall?
This recall was issued by the FDA Devices on October 14, 2015. Severity: Moderate. Recall number: Z-0021-2016.