Agency classClass IIOur severity:High FDA (Devices)·Z-1247-2019·Announced 2019-05-08

Siemens CT Scanners Recalled for Dual Energy Scan Abortion Risk

Siemens is recalling 53 SOMATOM Definition AS CT scanners due to a software issue that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.

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 involves a risk of harm (scan abortion) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 53 units of the SOMATOM Definition AS computed tomography (CT) scanner, Model Number 8098027, with the Option syngo DE Scan for Single Source. These devices are intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The recall is due to a software issue found in syngo CT VB10A for Siemens Healthineers CT scanners with a single X-ray tube. This issue creates a potential risk of scans being aborted when using the optional Dual Spiral Dual Energy mode. The affected units were distributed nationwide in the United States.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the software issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product: SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Computed Tomography (CT) Scanner
Hazard: software-defect
scan-abort
Affected units: 53

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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