Agency classClass IIOur severity:High FDA (Devices)·Z-0475-2022·Announced 2022-01-19

CT Scanner Software Update Causes Head Image Quality Degradation

Siemens SOMATOM Definition Edge CT scanners with software version VB20_SP5 may produce degraded head images, increasing the risk of patient misdiagnosis. Devices have been 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 recall of a medical device with potential for patient harm through misdiagnosis. The rubric specifies that risk-of-harm products where injury has not been reported score at most 3. No illnesses or injuries are documented in the source.

Plain-English summary

Siemens Medical Solutions USA, Inc is recalling specific SOMATOM Definition Edge computed tomography (CT) scanner systems, Model 10590000, due to a software defect. The recalled units operate with software version VB20_SP5, which affects image processing and quality.

The software version leads to degradation of head image quality. This degradation creates a potential risk to patients through misdiagnosis, as medical professionals may rely on compromised images for diagnostic decisions.

The affected devices have been distributed nationwide to healthcare facilities. Specific serial numbers of the affected units have been identified by the manufacturer and reported to the FDA.

The recalled product

Product: SOMATOM Definition Edge -Computed tomography system Model 10590000
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic Imaging / CT Scanner
Hazard: image-quality-degradation
misdiagnosis-risk
software-defect

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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