The Recall Desk
HighFDA (Devices)·Z-2403-2019·Announced 2019-09-04

Siemens SOMATOM go.All CT Scanner Injector Holder Recall

Siemens Medical Solutions is recalling SOMATOM go.All CT scanners because the injector holder could fall off with the injector and storage box.

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 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.All computed tomography (CT) system, model #11061638. The recall involves all serial numbers of this specific model.

The recall was initiated because the injector holder could potentially fall off together with the injector and the storage box. This CT system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The affected units were 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. Healthcare facilities should contact Siemens Medical Solutions for instructions on how to address this issue.

The recalled product

Product
SOMATOM go.All; Models #11061638 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

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 →

Related recalls

Same manufacturer · Siemens Medical Solutions USA, Inc

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Same hazard · falling object

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