Device product
ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
Z-0942-2022
Product summary
- Event
- Event 89922
- Status
- Completed
- Classification
- Class II
- Quantity
- 14
- Official record key
device-enforcement:Z-0942-2022
Official wording
Reason: Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location
Code information: DI Numbers: 00856100006066, 00856100006080, 00856100006097, 00856100006110, 00856100006127,00856100006165
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.
Derived failure modes
-
Device software or design
Software issue