Agency classClass IIOur severity:High FDA (Devices)·Z-2269-2019·Announced 2019-08-21

Siemens CT Systems Recalled for Software Issues Causing Scan Aborts

Siemens is recalling SOMATOM Definition Edge CT systems due to four safety-related software issues in syngo.CT version VB10A that may result in 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 is classified as FDA Class II, and the hazard involves 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 Definition Edge computed tomography (CT) systems, Model Number 10590000. The recall is due to four potential safety-related software issues affecting systems that utilize syngo.CT software version VB10A. These issues may result in a scan abort.

The affected units were distributed nationwide in the United States. The recall covers specific serial numbers, including 83904, 83931, 83834, and others listed in the agency documentation.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the software issues and potential scan aborts.

The recalled product

Product: SOMATOM Definition Edge, Model Number 10590000 - 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…
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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