Agency classClass IIOur severity:High FDA (Devices)·Z-2270-2019·Announced 2019-08-21

Siemens SOMATOM CT Systems Recalled for Software Scan Abort Risk

Siemens is recalling SOMATOM Definition Flash CT systems due to four software issues that may cause scans to abort.

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) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling SOMATOM Definition Flash computed tomography (CT) systems, Model Number 10430603. The recall involves specific serial numbers 73008 and 98642. 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 is classified as Class II by the FDA.

The affected products were distributed nationwide in the United States. Siemens is the recalling firm. No specific instructions for consumers are provided in the source text, but the recall is directed at the medical devices themselves.

The recalled product

Product: SOMATOM Definition Flash, Model Number 10430603 - 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
Hazard: software-defect
scan-abort

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Serial Numbers: 73008 98642

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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