The Recall Desk
ModerateFDA (Devices)·Z-0692-2017·Announced 2016-12-14

Siemens Recalls SOMATOM Force CT Systems for Software Bugs

Siemens is recalling 48 SOMATOM Force CT systems to install a software update that fixes bugs causing image errors and scan aborts.

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, which typically corresponds to a Moderate severity score (2) when no hospitalizations or serious injuries are reported, fitting the criteria for minor labeling errors or low-risk contamination/voluntary precautionary recalls.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 48 units of the SOMATOM Force computed tomography (CT) system. The recall is voluntary and is being conducted to address software bugs identified through normal field monitoring and the Global Complaint Handling Process. The affected units are distributed nationwide in the United States.

The software update, version VA50A_SP3, corrects several issues including volumetric misrepresentations of high-contrast objects, sporadic scan aborts due to tube current or disk load issues, missing Microsoft hotfixes, and sporadic image artifacts. These defects can lead to incomplete image reconstruction or temporary scan interruptions.

Hospitals and medical facilities with these specific serial numbers should contact Siemens to schedule the installation of the software update. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
SOMATOM Force, System x-ray, tomography, computed
Affected units
48

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 (20)

  • Model Number 10742326
  • Serial Numbers: 75708
  • 75709
  • 75607
  • 75617
  • 75550
  • 75526 75512
  • 75567
  • 75536
  • 75711
  • 75514
  • 75600
  • 75563
  • 75510
  • 75454
  • 75540
  • 75571
  • 75500 75527
  • 75475
  • 75535

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

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