Agency classClass IIOur severity:High FDA (Devices)·Z-0474-2022·Announced 2022-01-19

Computed Tomography System Software May Degrade Head Image Quality

Siemens SOMATOM Edge Plus CT systems running software version VB20_SP5 may produce degraded head images, potentially leading to patient misdiagnosis.

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: FDA Class II recall with no reported illnesses or injuries. The hazard represents a potential risk of patient harm through diagnostic error without reported injury, meeting the criterion for High severity as a risk-of-harm device failure without yet-reported harm.

Plain-English summary

The SOMATOM Edge Plus Computed Tomography (CT) system, Model 1026700, manufactured by Siemens Medical Solutions USA, Inc., is subject to a recall. Eighty units with specific serial numbers distributed throughout the United States are affected.

Software version VB20_SP5 in these systems can cause degradation of head image quality. This image quality degradation increases the potential for diagnostic errors and patient misdiagnosis.

Healthcare facilities and imaging centers operating affected systems should verify their system serial number against the recall list. Contact Siemens Medical Solutions USA, Inc. for technical assistance and remediation options.

The recalled product

Product: SOMATOM Edge Plus-Computed tomography system Model 1026700
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging Equipment
Hazard: image-quality-degradation
misdiagnosis
Affected units: 80

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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