Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1940-2018·Announced 2018-06-06

Siemens SOMATOM Go.Up CT Scanner Recalled for Software Issue

Siemens is recalling 33 SOMATOM Go.Up 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, but the source text describes a potential software issue requiring rescans without reporting of injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 33 units of the SOMATOM Go.Up CT scanner (Material Number 11061628) 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 specific serial numbers affected range from 108052 to 108143 and 108145.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the software issue and manage any necessary patient rescans.

The recalled product

Product: SOMATOM Go.Up, Material Number 11061628 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
Affected units: 33

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: 108052
108053
108054
108055
108056
108057
108058
108059
108060
108061
108062
108063
108064
108065
108066
108067
108068
108069
108070
108071

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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