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syngo.via RT Image Suite upgraded to VB60 running on… recallZ-0995-2022 · Siemens Medical Solutions USA, Inc · initiated Mar 7, 2022

Terminated

Is my device affected?

  1. 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.
  2. 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.
  3. 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-0995-2022
Status
Terminated
Initiated by the company
Mar 7, 2022
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
1 (US)
Product code
JAK
FDA submissions
K211373
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.Up Model Number 11061620. 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: 04056869051314, Serial Number 112261

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

5 devices cleared under K211373 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 89915).

Sources and updates

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