The Recall Desk
ModerateFDA (Devices)·Z-0597-2016·Announced 2016-01-13

Siemens Syngo X-Workplace Software Recall for Incorrect Measurement Display

Siemens is recalling Syngo X-Workplace software version VD10E because it may display incorrect length measurements, potentially leading to the selection of medical devices of the wrong size.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that the consequence is the need to exchange a device of the wrong size, with no reported injuries or illnesses. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary measures where harm has not been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling software version VD10E for the Syngo X-Workplace picture archiving and communication system. The recall involves 73 units distributed nationwide across 26 states, including Alabama, Arizona, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Wisconsin.

The recall is due to a potential post-processing software issue that occurs when using the "4D" tabcard. Specifically, when images are acquired with a CT scanner with a tilted gantry, the software may display an incorrect, too-small length measurement in the multiplanar reconstructions (MPRs) within a 2x2 layout. This error could result in healthcare providers selecting a medical device of the wrong size, which would then need to be exchanged.

Healthcare facilities that have purchased or received this specific software version should contact Siemens Medical Solutions USA, Inc. for further instructions on how to resolve the issue. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
Affected units
73

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Software Version: SW VD-10E

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →