Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1918-2019·Announced 2019-07-10

Siemens SOMATOM go.Top CT Systems Recalled for Performance Issues

Siemens Medical Solutions is recalling 30 SOMATOM go.Top CT systems due to potential performance problems that may interrupt scanning workflows and delay patient diagnoses.

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 only workflow interruptions and delays in diagnosis without reporting any injuries, illnesses, or structural defects, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 30 units of the SOMATOM go.Top (Model #1161640) computed tomography (CT) system. The affected units are equipped with syngo.CT software versions VA20A, VA20A_SP0, or VA20_SP1. These systems are intended to generate and process cross-sectional images of patients to aid in diagnosis, treatment preparation, and radiation therapy planning.

The recall is being issued because the devices may experience potential sporadic performance problems. These issues can result in scanning workflow interruptions and unexpected user notifications, which may cause delays in diagnosis or patient scans. The recall is classified as Class II by the FDA.

The affected units were distributed nationwide in the United States, including the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and Puerto Rico. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on resolving the performance issues.

The recalled product

Product: SOMATOM go.Top (Model #1161640), 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 images…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Computed Tomography (CT) Scanner
Hazard: performance-failure
diagnostic-delay
Affected units: 30

Distribution

Distributed nationwide across the United States.

The notice also names 33 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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