Agency classClass IIOur severity:High FDA (Devices)·Z-2274-2019·Announced 2019-08-21

Siemens SOMATOM Force CT Systems Recalled for Software Scan Abort Issues

Siemens Medical Solutions is recalling SOMATOM Force CT systems due to four software issues that may cause scan aborts.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 high-risk medical device (CT scanner) where a software defect could lead to a scan abort, representing a risk of harm or diagnostic failure, but the source text does not report any actual injuries or illnesses.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling SOMATOM Force computed tomography (CT) systems, Model Number 10742326. The recall affects systems utilizing syngo.CT software version VB10A. The products were distributed nationwide in the United States.

The recall is due to four potential safety-related software issues. These issues may result in a scan abort, which could interrupt the imaging process. The source text does not report any specific injuries, illnesses, or deaths associated with this recall.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the software issues. Consumers should not use the affected systems for diagnostic imaging until the software has been updated or resolved by the manufacturer.

The recalled product

Product: SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Computed Tomography (CT) Systems
Hazard: software-defect
scan-abort

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

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