Data Foundry

Medical device recalls 2016

SOMATOM Force — Class II medical device recall Z-0692-2017

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-12-14, distributed nationwide. Siemens is providing software update version VA50A_SP3 to address the software bugs that were identified throu

Recall numberZ-0692-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSiemens Medical Solutions USA, Inc, Malvern, PA, United States
Recall initiated2016-10-20
Classified2016-12-02
Reported by FDA2016-12-14
Terminated2017-05-30
DistributedNationwide (US)
Quantity48 units
Reason classessoftware
Serial numbers75454, 75458, 75460, 75464, 75467, 75475, 75476, 75478, 75481, 75482, 75487, 75493, 75500, 75501, 75510, 75512, 75513, 75514, 75515, 75524, 75526, 75527, 75528, 75532, 75535 and 23 more
Model numbers10742326

Product

SOMATOM Force, System x-ray, tomography, computed

Reason for recall

Siemens is providing software update version VA50A_SP3 to address the software bugs that were identified through normal field monitoring and the Global Complaint Handling Process. Correction for the problems are as follows: 1. Correction to volumetric misrepresentations of high contrast objects when using ADMIRE. 2. Correction to highly sporadic scan aborts due to temporarily tube currents at 0mA. 3. Correction to missing Microsoft Hotfixes (MS16-001, MS15-135, MS15-088, MS15-048). 4. Correction to highly sporadic image artifacts caused by error signals from high voltage chain at extremely high tube currents. 5. Correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed. 6. Correction to highly sporadic scan aborts due to temporarily high disk load of system disk. 7. Correction to highly sporadic image artifacts generated by scatter correction in case of tube arcings.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0692-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.