The Recall Desk
HighFDA (Devices)·Z-0107-2016·Announced 2015-10-14

Siemens SOMATOM Force CT Systems Recalled for Software and Firmware Bugs

Siemens Medical Solutions USA is recalling 21 SOMATOM Force computed tomography systems due to software and firmware bugs.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves software and firmware bugs in a diagnostic medical device, which poses a risk of harm through inaccurate imaging without reported injuries.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 21 units of the SOMATOM Force computed tomography x-ray system. The recall is due to software and firmware bugs in the devices. These systems are intended to generate and process cross-sectional images of patients.

The affected devices are identified by Model Number 10742326 and specific serial numbers ranging from 75437 to 75515. The recall covers units distributed nationwide. The agency has classified this recall as Class II.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the software and firmware issues. Consumers do not use these devices directly, but patients who have had imaging performed on these systems should consult their healthcare provider if they have concerns about the accuracy of their results.

The recalled product

Product
SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
Affected units
21

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)

  • and 75501.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

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