Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1245-2019·Announced 2019-05-08

Siemens CT Scanner Recall for Potential Scan Abortion in Dual Energy Mode

Siemens Medical Solutions is recalling 53 SOMATOM Definition Edge CT scanners due to a software issue that may cause scans to abort in 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a software issue causing scan abortion without reported injuries or illnesses, fitting the criteria for a moderate, precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 53 units of the SOMATOM Definition Edge computed tomography (CT) scanner, Model Number 10590000. 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 that creates a potential risk of scans being aborted when using the optional Dual Spiral Dual Energy mode on scanners with a single X-ray tube.

The affected units were distributed nationwide in the United States. The recall covers specific serial numbers listed in the agency documentation. No injuries or illnesses have been reported in connection with this recall.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the software issue. Consumers and patients should consult their healthcare providers regarding the status of their imaging equipment.

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.
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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