Agency classClass IIOur severity:High FDA (Devices)·Z-2273-2019·Announced 2019-08-21

Siemens SOMATOM Edge Plus CT Systems Recalled for Software Issues

Siemens is recalling SOMATOM Edge Plus CT systems due to four safety-related software issues in syngo.CT version VB10A 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 potential for safety-related issues that may result in a scan abort, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling SOMATOM Edge Plus computed tomography (CT) systems, Model Number 10267000. The recall involves specific serial numbers listed in the agency record. 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 affecting systems utilizing syngo.CT software version VB10A. These issues may result in a scan abort. The source text does not specify the exact nature of the software defects or the specific patient safety consequences beyond the interruption of the scan.

The affected units were distributed nationwide in the United States. The source text does not provide instructions for consumers or healthcare facilities on how to address the recall, nor does it report any injuries or illnesses associated with the defect.

The recalled product

Product: SOMATOM Edge Plus, Model Number 10267000 - 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…
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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