High FDA (Devices)·Z-2402-2019·Announced 2019-09-04

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

Siemens is recalling 10 SOMATOM go.All CT scanners because the injector holder could fall off. The units are distributed in 20 US states.

What this means for you

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 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 10 units of the SOMATOM go.All computed tomography (CT) system, model #11061630. The recall is due to a potential safety hazard where the injector holder could fall off together with the injector and the storage box.

The affected units are distributed nationwide in the following states: FL, KS, WI, NE, MS, OH, TX, NY, LA, IN, IL, OK, MI, GA, NJ, AK, CT, AL, and MD. The specific serial numbers for the recalled units are 117515, 117476, 117529, 117517, 117505, 117495, 117482, 117496, 117533, and 117535.

This recall is classified as Class II by the FDA. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect.

The recalled product

Product: SOMATOM go.All; Models #11061630 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
Affected units: 10

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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