Agency classClass IIOur severity:High FDA (Devices)·Z-2399-2019·Announced 2019-09-04

Siemens SOMATOM go.Now CT Systems Recalled for Injector Holder Risk

Siemens is recalling SOMATOM go.Now CT systems because the injector holder could fall off with the injector and storage box.

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 'High' severity criteria.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the SOMATOM go.Now computed tomography (CT) system, specifically models #11061610 and #11061618. The recall is due to a potential safety issue where the injector holder could fall off together with the injector and the storage box.

The affected units were distributed nationwide in the United States, including 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 recall applies to all serial numbers for these specific models.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. The CT system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The recalled product

Product: SOMATOM go.Now; Models #11061610 & 11061618 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

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 (1)

All serial numbers

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 →

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