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SOMATOM Force with software syngo.CT VB20 Model #10742326

FDA Device Recall #Z-0283-2022 — Class II — August 30, 2021

Recall Summary

Recall Number Z-0283-2022
Classification Class II — Moderate risk
Date Initiated August 30, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 232 units

Product Description

SOMATOM Force with software syngo.CT VB20 Model #10742326

Reason for Recall

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

Distribution Pattern

US Nationwide distribution.

Lot / Code Information

Serial Numbers: 75708 75765 76356 76406 75550 75879 76211 76294 75714 75790 75709 76019 75949 76166 76175 76170 76156 76162 76169 75607 76186 94851 75984 75784 76397 76221 75789 76326 75617 75526 76199 75512 75775 75567 76298 76279 75536 75807 76379 76408 76231 76232 75711 75716 75514 76353 75875 75899 75770 76152 75600 76357 75994 75563 76046 76089 75794 76366 76374 76193 75974 76059 76196 75897 76241 75510 76274 76292 76343 75892 75792 75535 75820 75754 75755 75993 75916 75971 75893 75944 75923 75540 76027 76362 76454 75739 75980 76217 76091 76101 75571 75848 76329 75818 76138 75850 75973 75437 75500 75527 75953 75885 76074 76385 75728 76142 76205 76064 76337 76090 76405 75939 75475 76147 75877 75727 76163 76057 75481 75439 75776 75450 75482 76237 75760 76403 75710 76056 76080 76118 75806 75808 76114 75588 75476 75931 76228 75890 76320 76203 75493 75900 76387 75528 75467 75823 76332 76334 75454 76003 75761 76207 75814 76416 75906 76097 75602 75487 76248 75837 75787 75743 75793 76010 76061 76202 76208 76441 75478 76415 76041 75936 75959 76275 75905 76293 76440 75942 75941 75604 75805 75513 76377 75884 76439 76006 75867 75532 75919 76140 76050 75913 76190 76181 76424 75843 76016 75983 75460 75555 76418 76368 76168 75524 75778 75515 76411 75610 75559 75501 75570 75769 76189 75774 76280 75849 76236 75788 76000 76073 75752 75999 75976 76008 75616 75750 76258 75576 75845 75852 75605 76001

Other Recalls from Siemens Medical Solutions USA, Inc

Recall # Classification Product Date
Z-1175-2026 Class II Interventional Fluoroscopic X-Ray System: LUMIN... Dec 29, 2025
Z-1174-2026 Class II Interventional Fluoroscopic X-Ray System: LUMIN... Dec 29, 2025
Z-1241-2026 Class II NAEOTOM Alpha.Prime Software applications: s... Dec 19, 2025
Z-1240-2026 Class II NAEOTOM Alpha Software applications: syngo.C... Dec 19, 2025
Z-1239-2026 Class II SOMATOM X.ceed Software applications: syngo.... Dec 19, 2025

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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