Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1939-2018·Announced 2018-06-06

Siemens SOMATOM go.Now CT Scanner Software Recall

Siemens Medical Solutions is recalling 4 SOMATOM go.Now CT scanners in the US due to a potential software issue that may require patient rescans.

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 the hazard is a potential software issue causing rescans without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 4 units of the SOMATOM go.Now CT scanner (Material Number 11061618) in the United States. The recall is due to a potential software issue that may cause the need for necessary patient rescans.

The affected units are distributed nationwide in the US, including in states such as AR, CA, CT, FL, GA, IL, IN, KS, KY, MO, ND, NY, OH, OK, SD, TN, TX, and VA. The product is also distributed in numerous countries worldwide. Specific serial numbers for the affected units are listed in the official recall documentation.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the software issue and potential patient rescans.

The recalled product

Product: SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — CT Scanner
Hazard: software-defect
patient-rescan
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 (20)

Serial Numbers: 106041
106051
106052
106053
106054
106055
106056
106057
106058
106059
106060
106061
106062
106065
106066
106067
106068
106069
106070
106071

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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