SOMATOM Scope ( Model 10967666) recallZ-2476-2018 · Siemens Medical Solutions USA, Inc · initiated Feb 1, 2018
Class II Terminated All recalls posted in March 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A potential risk of unnecessary radiation exposure due to a software issue
FDA root cause category: Software design
What the company is doing
Customers were sent notification letter via USPS with Certified Mail Receipts and Electronic Receipts.
Recall details
- Recall number
- Z-2476-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 1, 2018
- Posted by the FDA
- Mar 30, 2018
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product code
- JAK
- FDA submissions
- K140912
- Distribution
- Nationwide
Product description
SOMATOM Scope ( Model 10967666)
Code information (models, lots, serial numbers)
Serial No. 99329 98809 98886 99041 91203 91342 91475 98908 99019 99199 99248 99278 91286 98840 90872 90811 91486 98925 99049 91176 90939 91417 99258 91206 99296 91201 99295 99004 98991 90916 91090 99305 99179 91213 91402 91196 99244 90942 91133 91393 91506 99110 91494 91132 91204 98807 98875 99015 91418 91474 91108 91178 98926 91057 91179 91360 91367 99150 91310 91473 91396 99111 91263 91543 91190 91191 90907 91265 91416 99127 99255 99018 91355 91419 98814 91369 91222 91291 99274 99005 91376 91081 98855 91264 98788 90906 91325 91256 91038
Other devices under the same FDA submission
2 devices cleared under K140912 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SOMATOM Scope 10046799Siemens Healthcare GmbH · System, x-ray, tomography, computed1 death4 reports
- SOMATOM Scope 10967666Siemens Shanghai Medical Equipment Ltd. · System, x-ray, tomography, computed1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 79665).
- Z-2474-2018 · TerminatedSOMATOM Perspective (Model 10495568)
- Z-2475-2018 · TerminatedSOMATOM Perspective 16 (Model 10891666)
- Z-2477-2018 · TerminatedSOMATOM Scope Power (Model 10967888)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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