Z-0942-2022 Class II
FDA device recall Z-0942-2022 was initiated by Varian Medical Systems Imaging Laboratory GmbH on March 21, 2022 and is designated Class II. Reason for recall: Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location Affected quantity: 14.
Recall Details
- Product Type
- Devices
- Report Date
- April 20, 2022
- Initiation Date
- March 21, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14
Product Description
ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
Reason for Recall
Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location
Distribution Pattern
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.
Code Information
DI Numbers: 00856100006066, 00856100006080, 00856100006097, 00856100006110, 00856100006127,00856100006165