FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
- Recall number
- Z-1748-2018
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
- Status
- Terminated
- Initiated
- 2017-11-08
- Posted
- not on file
- Terminated
- 2023-05-18
- Reason
- 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
- 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
- 91
- Distribution
- Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K142955"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28