The Recall Desk
HighFDA (Devices)·Z-0995-2022·Announced 2022-05-04

CT Scanner Software Update May Display Incorrect Laser Offset Coordinates

Siemens CT scanner software upgrade may cause incorrect laser offset coordinates to display during patient positioning. No injuries reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall affecting a high-risk product (radiation therapy positioning system). The hazard—software-induced display error affecting patient positioning accuracy—creates a risk of harm. However, no injuries have been reported, so per the rubric, the score is 3 for risk-of-harm products without reported injury.

Plain-English summary

This recall affects the syngo.via RT Image Suite software (VB60 version) running on Siemens SOMATOM go.Up CT scanners (Model 11061620) equipped with syngo.via VB60 server software and syngo.CT VA40A scanner software. The recall applies to units distributed worldwide, including multiple U.S. states and international locations.

When the software was upgraded to version VB60, the system automatically changed laser configuration settings for the 'markerless workflow' function. This change causes the Patient Marking step to display incorrect laser offset coordinates. These coordinates are used to position patients for radiation therapy, and accurate positioning is essential for safe treatment.

Healthcare facilities with Siemens SOMATOM go.Up CT scanners running the affected software versions are affected. The FDA has identified distribution in the United States across AL, AR, AZ, CA, CO, CT, IL, IN, KY, MD, MO, ND, NH, NY, OH, OR, PA, SD, TX, and VA, as well as Argentina, Austria, Bahrain, Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Switzerland, and the United Kingdom.

No patient injuries or deaths have been reported. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. to obtain updated software or guidance on verifying correct laser coordinates during patient positioning until the issue is resolved.

The recalled product

Product
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.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — CT Scanner / Radiation Therapy
Hazard
  • software-malfunction
  • coordinate-error
  • positioning-inaccuracy

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Partial UDI: 04056869051314
  • Serial Number 112261

Distribution

Distributed nationwide across the United States.

Related recalls

Same category