Agency classClass IIOur severity:High FDA (Devices)·Z-0473-2022·Announced 2022-01-19

CT Scanner Software Defect May Degrade Image Quality

Software version VB20_SP5 in certain Siemens CT scanners may degrade head image quality, increasing misdiagnosis risk. The recall affects 794 units distributed nationwide.

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 is an FDA Class II medical device recall involving a software defect that degrades diagnostic image quality and creates a theoretical risk of patient misdiagnosis. No illnesses or injuries have been reported; the hazard is the potential for diagnostic error rather than direct patient harm.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the SOMATOM Definition AS-Computed tomography system (Model 8098027) due to a software defect in version VB20_SP5. The recall affects 794 units distributed nationwide across the United States.

The software defect may lead to degradation of head image quality during diagnostic scans. This degradation creates a potential risk that patients could be misdiagnosed based on the degraded images.

Healthcare facilities and diagnostic imaging centers using the affected equipment should immediately check if their systems are running software version VB20_SP5 by referring to the provided serial numbers. Facilities with affected units should contact Siemens Medical Solutions USA, Inc. for remediation instructions and should consider whether to suspend clinical use of the equipment until the software issue is resolved.

The recalled product

Product: SOMATOM Definition AS-Computed tomography system Model 8098027
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic Imaging / CT Scanner
Hazard: image-quality-degradation
misdiagnosis-risk
Affected units: 794

Distribution

Distributed nationwide across the United States.

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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