Baden, N/A, Switzerland
Varian Medical Systems Imaging Laboratory GmbH recalls
1 recall recorded since 2018, most recently on 21 March 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 21 March 2022
- Reason
- Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of MI, KS, OH, VA, DC, FL, PA, OK, MN, AZ and the countries of South Korea, Netherlands, Poland, China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0942-2022
- ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.