Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0606-2017·Announced 2016-11-23

Siemens Recalls SOMATOM Definition AS CT Systems for Software Update

Siemens is recalling seven SOMATOM Definition AS CT systems to install a software update that fixes bugs and corrects potential safety issues.

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 source text explicitly states no illnesses or injuries are reported and describes the action as a software update to correct potential safety issues, fitting the criteria for a voluntary precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling seven SOMATOM Definition AS computed tomography (CT) x-ray systems. The recall involves a software update designed to provide bug-fixes that improve system performance and correct potential safety issues.

The affected systems are distributed nationwide to Michigan, New York, California, Kentucky, North Dakota, and Nebraska. The specific serial numbers for the recalled units are 96020, 96047, 74192, 83398, 96011, 83387, and 96029. The source text notes that the software update is intended for systems with software version VA48A_SP2 and Care Contrast license.

The source text does not specify the exact nature of the safety issues or provide instructions for consumers or healthcare facilities on how to proceed with the update. No illnesses or injuries are reported in the source text.

The recalled product

Product: SOMATOM Definition AS, 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
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: 8098027 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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