The Recall Desk
ModerateFDA (Devices)·Z-1915-2019·Announced 2019-07-10

Siemens SOMATOM go.Up CT Scanner Recalled for Performance Issues

Siemens Medical Solutions is recalling nine SOMATOM go.Up CT scanners due to sporadic performance problems that may interrupt scanning workflows and delay patient diagnosis.

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 the hazard as sporadic performance problems causing workflow interruptions and delays in diagnosis, with no reports of serious injury or death, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling nine units of the SOMATOM go.Up (Model #11061610) computed tomography (CT) system. The affected units are equipped with syngo.CT software versions VA20A, VA20A_SP0, or VA20_SP1. The recall is being conducted under FDA recall classification Class II.

The recall is due to potential sporadic performance problems that may result in scanning workflow interruptions and unexpected user notifications. These issues may cause a delay in diagnosis or patient scans. The affected units were distributed nationwide in the United States, including in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, SC, TX, VA, WA, and WI, as well as in Puerto Rico.

Facilities with these specific serial numbers (112552, 112551, 112555, 112519, 112542, 112545, 112541, 112536, 112573) should contact Siemens Medical Solutions USA, Inc. for further instructions on resolving the performance issues.

The recalled product

Product
SOMATOM go.Up (Model #11061610) 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 images deli
Affected units
9

Distribution

Distributed nationwide across the United States.

The notice also names 33 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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