Z-1748-2018Class II

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

Name: Z-1748-2018 SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
Creator: Siemens Medical Solutions USA, Inc
Published: 2017-11-08
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-11-08 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system on 2017-11-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1748-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-08
Posted: 2018-05-15
Terminated: 2023-05-18
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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 tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 91
Distribution: Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1748-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1745-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-15
Z-1746-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-15
Z-1747-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-15
Z-1748-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-15

Product code JAK

K142955Class IISOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope PowerSiemens Medical Solutions USA, Inc. / cleared 2015-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)