Agency classClass IIOur severity:High FDA (Devices)·Z-0283-2022·Announced 2021-12-01

CT Scanner Software Issue May Interrupt Diagnostic Workflows and Delay Diagnoses

Siemens SOMATOM Force CT scanners with software syngo.CT VB20 may experience workflow interruptions, causing diagnosis delays and requiring additional patient scans and contrast media. No illnesses or injuries have been reported.

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: Class II medical device recall with no reported illnesses or injuries. The software defect causes operational interruptions that result in diagnosis delays and require additional patient scans and contrast media administration, which carry inherent medical risks including radiation exposure and potential contrast adverse reactions. Per the rubric, recalls with no reported illness but potential for harm score at most 3, making this High severity.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 232 SOMATOM Force CT scanners with software syngo.CT VB20 (Model #10742326) distributed nationwide in the United States. The recall applies to units with or without software versions VB20_SP1, SP2, SP3, or SP4.

The software issue may cause workflow interruptions during scanning operations. When these interruptions occur, they result in delays in patient diagnosis, necessitate additional patient rescans, and require administration of additional contrast media. These consequences carry medical risks including radiation exposure from additional scans and potential adverse reactions from additional contrast administration.

No illnesses or injuries have been reported in connection with this software issue. Healthcare facilities operating affected SOMATOM Force units should be aware of this defect and the risks associated with workflow interruptions. The FDA classified this as a Class II recall.

The recalled product

Product: SOMATOM Force with software syngo.CT VB20 Model #10742326
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic Imaging Equipment
Hazard: software-defect
workflow-interruption
diagnosis-delay
unnecessary-radiation-exposure
Affected units: 232

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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