The Recall Desk
HighFDA (Devices)·Z-1748-2018·Announced 2018-05-23

Siemens SOMATOM Force CT scanners recalled for radiation exposure risk

Siemens is recalling 91 SOMATOM Force CT scanners due to a software issue that may cause unnecessary radiation exposure.

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 involves a risk of unnecessary radiation exposure, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 91 units of the SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system. The recall is due to a potential risk of unnecessary radiation exposure caused by a software issue in the CARE Dose4D algorithm.

The affected devices were distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico. The source text notes that the software issue was found in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash, and SOMATOM Force.

The source text does not specify specific actions for consumers or patients, nor does it report any illnesses or injuries resulting from the defect.

The recalled product

Product
SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
Affected units
91

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 4 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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