Agency classClass IIOur severity:High FDA (Devices)·Z-0288-2022·Announced 2021-12-01

Siemens SOMATOM Confidence CT Scanners Recalled for Software-Related Workflow Interruptions

Siemens SOMATOM Confidence CT scanners may experience software-related workflow interruptions that could delay patient diagnosis. The recall affects 104 units nationwide; affected facilities should contact the manufacturer for remediation instructions.

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: This FDA Class II recall involves medical imaging equipment without reported illnesses or injuries. The software defect poses a risk of delayed patient diagnosis through workflow interruptions, meeting the rubric criterion for High-severity risk-of-harm products where injury has not yet been reported.

Plain-English summary

The U.S. Food and Drug Administration has issued a Class II recall of Siemens SOMATOM Confidence CT scanners (Model #10590100) with syngo.CT VB20 software. The recall affects 104 units distributed nationwide.

The software syngo.CT VB20, including versions SP1 through SP4, may cause workflow interruptions during the CT scanning process. These interruptions can result in delays in diagnosis, may require patients to undergo additional rescans, and may necessitate additional contrast media administration.

Facilities with affected devices should verify their unit serial numbers against the recall list. Contact Siemens Medical Solutions USA, Inc. for remediation instructions.

The recalled product

Product: SOMATOM Confidence with software syngo.CT VB20 Model #10590100
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Medical Imaging Equipment
Hazard: workflow-interruption
delayed-diagnosis
software-malfunction
Affected units: 104

Distribution

Distributed nationwide across the United States.

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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