The Recall Desk
HighFDA (Devices)·Z-0997-2022·Announced 2022-05-04

CT Scanner Software Update May Display Incorrect Laser Positioning Coordinates

Siemens CT scanner imaging software upgraded to version VB60 may display incorrect laser offset coordinates during patient marking. Fourteen units are affected in the United States.

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 with no reported injuries. The defect involves a radiation therapy system where incorrect positioning display poses potential patient risk, matching the rubric criterion for risk-of-harm products where harm has not been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling syngo.via RT Image Suite software upgraded to version VB60, which runs on SOMATOM go.Open Pro CT scanners (Model 11061670). Fourteen units are affected in the United States.

The software upgrade automatically changes laser configuration settings for the 'markerless workflow' feature. This change may cause incorrect laser offset coordinates to be displayed in the Patient Marking step.

The affected units are distributed across the United States and internationally in 16 countries.

The recalled product

Product
syngo.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 syngo.CT VA40A after upgrade.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Imaging / Radiation Therapy
Hazard
Affected units
14

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 (15)

  • Partial UDI: 04056869249247
  • Serial Numbers 130088
  • 130081
  • 130075
  • 130090
  • 130087
  • 130074
  • 130069
  • 130091
  • 130092
  • 130086
  • 130079
  • 130089
  • 130077
  • 130071

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Siemens Medical Solutions USA, Inc

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Same hazard · software configuration error

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