The Recall Desk
ModerateFDA (Devices)·Z-0465-2013·Announced 2012-12-12

Siemens syngo.plaza Radiological Image Processing System Software Update Recall

Siemens Medical Solutions USA, Inc. is recalling 15 syngo.plaza systems to address unintended software behavior that may affect system performance.

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 describes a software performance issue (log filling) without reporting any patient injuries, deaths, or significant adverse health consequences, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 15 units of the syngo.plaza Radiological Image Processing System (Model number 10 592 457). The firm issued an Update Instruction (SY050/12/S) to provide a software update that addresses unintended behavior in the system.

The recall is due to a software issue where patient rename messages for the same patient are continually processed for several days. This behavior fills up the 'pcvdbsrv' log and potentially affects the performance of the system. The source text notes that data could be affected, though specific details regarding data loss or corruption are not fully detailed in the provided excerpt.

The affected units were distributed nationwide in the United States, including the states of California, Florida, Georgia, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, and Wisconsin. Users of these systems should contact Siemens Medical Solutions USA, Inc. to obtain and install the software update.

The recalled product

Product
Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
Affected units
15

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)

  • Model number 10 592 457

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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