SOMATOM Definition Edge System, x-ray, tomography, computed 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: December 21, 2016 Initiated: November 15, 2016 #Z-0744-2017
Product Description
SOMATOM Definition Edge System, x-ray, tomography, computed 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 update that provides software and firmware bug-fixes to improve system performance
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 104 systems
- Distribution
- Nationwide Distribution
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
SOMATOM Definition Edge System, x-ray, tomography, computed 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: 104 systems.
Why was this product recalled? ▼
Software update that provides software and firmware bug-fixes to improve system performance
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 21, 2016. Severity: Moderate. Recall number: Z-0744-2017.
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