Reported Jan 13, 2016 · Terminated
Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
- Lot codes and dates
- Software VersionSW VD-10E
- Amount recalled
- 73 units
Where it was sold
Why it was recalled
Potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner with a tilted gantry. In a 2x2 layout, the 4D tabcard will show an incorrect, too small length measurement. This could result in selecting a device of the wrong size, which then needs to be exchanged.
This product could cause temporary or reversible health problems — stop using it.
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