Agency classClass IIOur severity:High FDA (Devices)·Z-2400-2019·Announced 2019-09-04

Siemens SOMATOM go.Up CT Systems Recalled for Falling Injector Holder

Siemens is recalling 18 SOMATOM go.Up CT systems because the injector holder could fall off, posing a risk of injury.

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 involves a risk-of-harm product (falling equipment) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 18 units of the SOMATOM go.Up computed tomography (CT) system, model #11061620. The recall is due to a defect where the injector holder could potentially fall off together with the injector and the storage box.

The affected units were distributed nationwide in the United States, specifically in the states of 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 111232, 111409, 111332, 111370, 111371, 111383, 111378, 111352, 111299, 111273, 111373, 111289, 111339, 111317, 111333, 111297, 111237, and 111303.

Healthcare facilities and consumers with these specific serial numbers should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product: SOMATOM go.Up; Models #11061620 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) System
Hazard: falling-object
impact-injury
Affected units: 18

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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