Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2626-2016·Announced 2016-08-31

Siemens SOMATOM Definition Edge CT Systems Recalled for Injector Failure

Siemens is recalling four CT systems because a software error prevents the contrast agent injector from starting in automatic or coupled modes.

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 that the error results in a failed examination rather than a direct physical hazard or injury, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling four SOMATOM Definition Edge computed tomography (CT) x-ray systems, Model # 8098027, with software version VA48A-SP2. The affected serial numbers are 96020, 96047, 96011, and 96029. These systems were distributed to facilities in Michigan, New York, California, Kentucky, North Dakota, and Nebraska.

The recall is due to an internal communication error between the firmware and the software of the components. This error causes the planned CT scan to execute properly, but the injector is not started. As a result, the contrast agent is not injected, and the desired examination result is not achieved. The issue only affects the automatic mode or coupled mode and does not affect the manual control of the injector.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to resolve the issue. No injuries or illnesses have been reported in connection with this recall.

The recalled product

Product: SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Computed Tomography (CT) Systems
Hazard: software-error
failed-examination
Affected units: 4

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 (4)

Model # 8098027 Serial # 96020
96047
96011
and 96029

Distribution

Distributed in 6 states:

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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