FDA recall Z-2445-2021

Product

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).

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2021-08-16

Report date

2021-09-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2445-2021