CT scanner software upgrade causes incorrect laser position display
Siemens CT scanner software upgrade may display incorrect laser offset coordinates during patient marking. This defect affects 15 systems in the US across multiple 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: FDA Class II recall with no reported illnesses or injuries. The software defect affects a risk-of-harm medical device (CT imaging system with laser positioning) where incorrect coordinate display could impair patient positioning accuracy and clinical decision-making.
Plain-English summary
Siemens Medical Solutions has recalled its syngo.via RT Image Suite software (version VB60) running on SOMATOM go.Sim CT scanners. When the software is upgraded, an automatic change in laser configuration settings for the "markerless workflow" function may cause incorrect laser offset coordinates to be displayed during the Patient Marking step.
This defect could affect the accuracy of patient positioning and marking during imaging procedures. The recall affects 15 systems distributed across 20 US states and 14 countries worldwide.
If you operate an affected system, contact your Siemens representative for instructions on correcting the laser configuration settings. Do not rely on laser offset coordinates displayed on the system until the issue is resolved.
The recalled product
- Product
- 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.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- software-defect
- coordinate-error
- mis-calibration
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 (16)
- Partial UDI: 04056869249230
- Serial Numbers 128123
- 128106
- 128109
- 128144
- 128124
- 128112
- 128132
- 128135
- 128114
- 128125
- 128113
- 128142
- 128107
- 128136
- 128133
Distribution
Distributed nationwide across the United States.
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