Recall – Potential for misdiagnosis due to SW related image quality degradation

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 1/19/2022
Class II

PRODUCT

SOMATOM Confidence – Computed tomography systems

Model: 10590100

Recall Number: Z-0472-2022

SOMATOM Definition AS-Computed tomography system

Model 8098027

Recall Number: Z-0473-2022

SOMATOM Edge Plus-Computed tomography system

Model 1026700

Recall Number: Z-0474-2022

SOMATOM Definition Edge -Computed tomography system

Model 10590000

Recall Number: Z-0475-2022

REASON

Software version VB20_SP5 may lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc. on 11/19/2021. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

108 units

DISTRIBUTION

U.S. Nationwide

Upcoming SoftwareCPR Training Courses:

Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

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Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.