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Recall Observatory FDA recall evidence

Device product

ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1

Z-0942-2022

March 21, 2022

Class II

Product summary

Firm
Varian Medical Systems Imaging Laboratory GmbH
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

    reason.device_software_design · v1.0.0

    Software issue