RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system d

FDA device recall Z-1679-2015 · posted 2015-05-27 · Terminated

Recall details

Recalling firm: RAYSEARCH LABORATORIES AB
Reason for recall: RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing.
Action taken: RaySearch sent a Device Correction letter dated May 8, 2015 via e-mailed to their customers. The letter identified the affected product, problem, actions to be taken by users and contact information.
Root cause: Software Design Change
Status: Terminated
Product code: MUJ
Quantity affected: Domestic: 539 units
Distribution: US Nationwide Distribution
Date initiated: 2015-05-08
Date posted: 2015-05-27
Date terminated: 2017-04-11
Location: Stockholm, Sweden

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