—#164183

Product

SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K142955
Affected lot / code info: Serial Numbers: 75708 75765 75714 75790 75709 75607 75784 75789 75617 75550 75526 75512 75775 75567 75536 75807 75711 75716 75514 75770 75600 75794 75563 75824 75768 75510 75792 75454 75754 75755 75540 75739 75806 75808 75571 75818 75437 75500 75527 75776 75728 75475 75535 75820 75727 75481 75439 75450 75482 75760 75710 75460 75476 75588 75493 75458 75528 75467 75823 75761 75602 75487 75804 75837 75743 75787 75793 75478 75604 75805 75513 75532 75843 75555 75788 75524 75778 75515 75559 75610 75501 75570 75769 75774 75752 75799 75616 75750 75576 75845 75605

Why it was recalled

There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.

Root cause (FDA determination)

Device Design

Action the firm took

Siemens Medical Solutions USA, Inc. will bring defect into Compliance noted below: 1.You will contact customers and initiate the actions to correct the failure to comply issue. 2. You will provide a software update to correct tube current calculations by the CARE Dose4D algorithm for head scans. 3.You will follow-up with consignees to verify the effectiveness of the software update. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) division office coordinator noted below are to be included. For further questions, please call (610) 448-6471.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.

Timeline

Recall initiated: 2017-11-08
Terminated: 2023-05-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164183. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.