The Recall Desk
ModerateFDA (Devices)·Z-0271-2014·Announced 2013-11-20

Siemens syngo.plaza Image Processing System Recalled for Patient Data Merge Error

Siemens is recalling 19 syngo.plaza image processing systems because a software function can cause unintended patient data merges when transferring data between systems.

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 does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 19 units of the syngo.plaza image processing system. The recall is due to an unintended behavior in the software's "Rename" functionality, which can cause an unintended patient merge if patient data is sent to another system.

This issue affects customers who transfer patient data between two or more syngo.plaza or syngo Imaging XS systems. The affected units are distributed nationwide, including in Missouri, Massachusetts, New York, Wisconsin, Ohio, California, Florida, North Carolina, Minnesota, and Washington.

The source text does not specify specific consumer actions or report any injuries or illnesses associated with this defect.

The recalled product

Product
Siemens syngo.plaza image processing system image processing radiological system
Affected units
19

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 (19)

  • Model Number 10592457 with serial numbers 100263
  • 100177
  • 100138
  • 100174
  • 100005
  • 100006
  • 100007
  • 100008
  • 100009
  • 100010
  • 100219
  • 100201
  • 100198
  • 100181
  • 100249
  • 100301
  • 100302
  • 100157
  • 100146

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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