PlainRecalls
FDA Devices Moderate Class II Ongoing

syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

Reported: September 22, 2021 Initiated: August 16, 2021 #Z-2445-2021

Product Description

syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

Reason for Recall

Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).

Details

Units Affected
126 units
Distribution
US Nationwide distribution.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 126 units.
Why was this product recalled?
Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).
Which agency issued this recall?
This recall was issued by the FDA Devices on September 22, 2021. Severity: Moderate. Recall number: Z-2445-2021.