ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
Check against the official notice below — it lists the full affected range.
Varian Medical Systems Imaging Laboratory GmbH has recalled ARIA Radiation Therapy Management software versions 13.6, 15.1, 15.5, 15.6, 16.0, and 16.1 due to a software issue in the treatment plan and image management application. The problem may cause mismatch values that could result in radiation treatment being delivered to the wrong location on a patient's body. A total of 14 units were distributed worldwide, including locations across multiple U.S. states (Michigan, Kansas, Ohio, Virginia, DC, Florida, Pennsylvania, Oklahoma, Minnesota, and Arizona) and international locations (South Korea, Netherlands, Poland, and China).
The source document does not specify a remedy or corrective action for affected consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location
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: 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. Quantity: 14 Lot/code info: DI Numbers: 00856100006066, 00856100006080, 00856100006097, 00856100006110, 00856100006127,00856100006165
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.