Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0607-2017·Announced 2016-11-23

Siemens Recalls CT Systems for Software Safety Bug Fixes

Siemens is releasing a software update for specific CT systems to correct potential safety issues and improve performance.

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 and involves a software update to correct 'potential safety issues' without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling seven SOMATOM Definition Edge computed tomography x-ray systems. The recall involves a software update that provides bug fixes to improve system performance and correct potential safety issues for customers with specific software versions and licenses.

The affected systems are distributed nationwide to Michigan, New York, California, Kentucky, North Dakota, and Nebraska. The recall specifically targets systems with software version VA48A_SP2 and the Care Contrast license. The update is intended to address safety concerns associated with the current software configuration.

Customers with these specific systems should contact Siemens to obtain and install the software update. The update is designed to mitigate the identified safety issues and ensure the systems operate as intended.

The recalled product

Product: SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Computed Tomography (CT) Scanner
Hazard: software-defect
safety-issue
Affected units: 7

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 (6)

Model Number: 1059000 Serial Numbers:96020
96047
74192
83398
96011
83387 96029

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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