Z-1746-2018Class II

SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system

Name: Z-1746-2018 SOMATOM Definition Edge (Model 10590000) 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 Definition Edge (Model 10590000) 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-1746-2018
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 Definition Edge (Model 10590000) 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: 134
Distribution: Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.
Product codes and lots: Serial Numbers:83249 83277 83632 83336 83401 83204 83562 83564 83582 83390 83088 83234 83235 83645 83321 83527 83332 83026 83281 83558 83546 83339 83244 83585 83613 83226 83330 83214 83271 83607 83403 83599 83246 83388 83021 83584 83591 83574 83210 83552 83541 83020 83626 83308 83375 83227 83359 83031 83520 83262 83557 83081 83292 83090 83544 83083 83096 83294 83319 83581 83056 83041 83363 83307 83236 83348 83567 83378 83399 83258 83084 83004 83237 83205 83014 83573 83233 83352 83569 83537 83355 83395 83621 83335 83278 83322 83392 83622 83276 83279 83327 83091 83371 83533 83597 83034 83059 83230 83254 83267 83055 83291 83046 83524 83044 83243 83637 83640 83232 83362 83306 83542 83257 83539 83094 83239 83398 83565 83313 83653 83347 83349 83323 83324 83618 83266 83387 83516 83627 83095 83042 83611 83633 83589

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1746-2018
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)