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
- Hazard
- software-configuration-error
- display-error
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.
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