The Recall Desk
ModerateFDA (Devices)·Z-1921-2019·Announced 2019-07-10

Siemens SOMATOM go.All CT Scanner Recalled for Performance Issues

Siemens is recalling 69 SOMATOM go.All CT scanners due to potential performance problems that may cause diagnostic delays or require patient rescans.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes only workflow interruptions and diagnostic delays without reporting any injuries, illnesses, or structural defects, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 69 units of the SOMATOM go.All computed tomography (CT) system, Model No. 11061638, equipped with syngo.CT software versions VA20A, VA20A_SP0, or VA20_SP1. The affected units were distributed nationwide in the United States, specifically in the states of Alabama, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New York, Ohio, Oklahoma, South Dakota, Tennessee, Texas, Virginia, and Wisconsin.

The recall is being issued due to potential sporadic performance problems. These issues may result in scanning workflow interruptions and unexpected user notifications. Consequently, the performance problems could lead to diagnostic delays or the need for patients to be rescanned.

This recall affects healthcare facilities that utilize the specific CT system for generating and processing cross-sectional images of patients. The system is intended to aid trained physicians and staff in diagnosis, treatment preparation, and radiation therapy planning, including low-dose lung cancer screening in high-risk populations. Users should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the affected units.

The recalled product

Product
SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. 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. The imag
Affected units
69

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)

  • 118151

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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