syngo.via RT Image Suite upgraded to VB60 running on… recallZ-0996-2022 · Siemens Medical Solutions USA, Inc · initiated Mar 7, 2022
Terminated
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
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
FDA root cause category: Software change control
What the company is doing
4/4/22 update: Urgent Medical Device Correction letter has not been issued. The proposed letter informs customers of software issue and workaround to resolve issue. It also requires electronic signature to acknowledge receipt of the notification. If you have additional questions contact the service organization at 1-800-888-7436.
Recall details
- Recall number
- Z-0996-2022
- Status
- Terminated
- Initiated by the company
- Mar 7, 2022
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 15 (US)
- Product code
- JAK
- FDA submissions
- K200524
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, IL, IN, KY, MD, MO, ND, NH, NY, OH, OR, PA, SD, TX, VA and the countries of Argentina, Austria, Bahrain, Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Switzerland, United Kingdom.
Product description
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Code information (models, lots, serial numbers)
Partial UDI: 04056869249230, Serial Numbers 128123, 128106, 128109, 128144, 128124, 128112, 128132, 128135, 128114, 128125, 128113, 128142, 128107, 128136, 128133
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SOMATOM go.Sim 11061660Siemens Healthcare GmbH · System, x-ray, tomography, computed2 recalls1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 89915).
- Z-0995-2022 · Terminatedsyngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo…
- Z-0997-2022 · Terminatedsyngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with…
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 16, 2026. Text above is shown as published by the FDA.
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