Reported Apr 27, 2022 · Ongoing
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 &…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- SIEMENS SOMATOM with software syngo CT VA30A_SP4
- ModelsSOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X
- cite 11330001 Intended UseComputed tomography x-ray system
- Lot codes and dates
- Software syngo CT VA30A_SP4
- Serial numbers
547 of 547 codes
106115106133106237106260106360106400106459106464106484106526106527106545106562108054108056108062108076108080108085108088108095108099108101108106108108108109108111108112108113108114108116108117108118108120108125108126108128108133108146108154108158108163108168108170108174108175108176108177108178108183111219111230111232111233111236111237111249111250111266111271
- UDISOMATOM go.Now 04056869051291 & 04056869051307 SOMATOM go.Up 04056869051314 & 04056869051321 SOMATOM go.All 04056869151564 & 04056869151588 SOMATOM go.Top 04056869151571 & 04056869151595 SOMATOM go.Sim 04056869249230 & 04056869239736 SOMATOM go.Open Pro 04056869249247 & 04056869239743 SOMATOM X.cite 04056869231044
- Amount recalled
- 547 units US
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient issues: Possible rescan , Unexpected X-Ray dose and additional contrast media, Delay in diagnosis, scan abort,and patient rescan
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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