Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172
FDA Recall Z-0065-2019 · Posted None
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Recalling FirmVision RT Ltd
Recall StatusTerminated
Product CodeIYE
Date Initiated2018-08-24
Date Terminated2022-07-08
Product Quantity690 systens
Reason for Recall
RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
Firm Action
Vision RT notified customers with Customer Information Bulletin dated August 24, 2018 to make them aware of the issue, how to spot it (in the unlikely event that it occurs) and how to deal with it. The customer contact also indicates that the issue is to be fixed with a firmware update and that this can be delivered remotely or installed on site by a service engineer,or transmit the firmware update to those customers whose systems can be accessed .
Root Cause
Software design
Distribution Pattern
Nationwide Foreign: Australia, Austria, Azerbaijan, Belgium, Brunei, Bulgaria, Canada, China, Croatia, Denmark, Finland, Georgia, Germany, India, Israel, Italy, Japan, Korea, Lithuania, Malaysia, Morocco, Norway, Poland, Portugal, Puerto Rico, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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