Agency classClass IIOur severity:High FDA (Devices)·Z-2271-2019·Announced 2019-08-21

Siemens SOMATOM Drive CT Systems Recalled for Software Safety Issues

Siemens Medical Solutions is recalling SOMATOM Drive 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 medical device with a risk of harm (scan abort) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling SOMATOM Drive computed tomography (CT) systems, Model Number 10431700. The recall involves specific serial numbers listed in the agency documentation. These systems are intended to generate and process cross-sectional images of patients for diagnostic and treatment planning purposes.

The recall is due to four potential safety-related software issues in systems utilizing syngo.CT software version VB10A. These issues may result in a scan abort. The recall covers systems distributed nationwide in the United States.

Healthcare facilities and users should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the software issues. The source text does not report any injuries or illnesses associated with this recall.

The recalled product

Product: SOMATOM Drive, Model Number 10431700 - 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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