Agency classClass IIOur severity:High FDA (Devices)·Z-2404-2019·Announced 2019-09-04

Siemens SOMATOM go.Top CT Scanner Recall for Falling Injector Holder

Siemens is recalling 12 SOMATOM go.Top CT scanners because the injector holder could fall off. The devices are distributed in 20 US states.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a component falling, which poses a risk of harm (impact injury) even though no injuries have been reported yet.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 12 units of the SOMATOM go.Top computed tomography (CT) system, Model #11061640. The recall is due to a safety concern where the injector holder could potentially fall off together with the injector and the storage box.

The affected devices were distributed nationwide in the following states: Florida, Kansas, Wisconsin, Nebraska, Mississippi, Ohio, Texas, New York, Louisiana, Indiana, Illinois, Oklahoma, Michigan, Georgia, New Jersey, Alaska, Connecticut, Alabama, and Maryland. The specific serial numbers for the recalled units are 119145, 119148, 119119, 119123, 119133, 119084, 119087, 119083, 119143, 119153, 119122, and 119120.

This is a Class II recall, indicating that use of the product could cause temporary or medically reversible adverse health consequences. The source text does not report any injuries or illnesses associated with this defect. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the potential falling hazard.

The recalled product

Product: SOMATOM go.Top; Models #11061640 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
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Computed Tomography (CT) Scanner
Hazard: falling-object
impact-injury
Affected units: 12

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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