FDA recall Z-0065-2019

Product

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

Reason for recall

RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB

Distribution

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.

Key facts

Status

Terminated

Initiation date

2018-08-24

Report date

2018-10-10

Termination date

2022-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

London, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0065-2019