Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1920-2019·Announced 2019-07-10

Siemens SOMATOM go.Now CT Systems Recalled for Performance Issues

Siemens is recalling 69 SOMATOM go.Now CT systems due to potential performance problems that may cause diagnostic delays or the need for 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. The hazard involves workflow interruptions and diagnostic delays rather than direct physical injury or death, fitting the criteria for a moderate severity recall involving potential adverse health consequences through delayed diagnosis.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 69 units of the SOMATOM go.Now computed tomography (CT) system, Model No. 11061618, equipped with syngo.CT software versions VA20A, VA20A_SP0, or VA20_SP1. The affected units were distributed nationwide in the United States, specifically in the states of Alabama, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New York, Ohio, Oklahoma, South Dakota, Tennessee, Texas, Virginia, and Wisconsin.

The recall is being conducted because the systems may experience potential sporadic performance problems. These issues can result in scanning workflow interruptions and unexpected user notifications. Consequently, patients may experience diagnostic delays or may require a rescan to obtain the necessary medical images.

This recall affects medical facilities that purchased or received these specific CT systems. Siemens is the recalling firm. Users should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the performance issues and manage affected patient workflows.

The recalled product

Product: SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Computed Tomography (CT) Scanner
Hazard: diagnostic-delay
performance-failure
Affected units: 69

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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