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
Reported: October 10, 2018 Initiated: August 24, 2018 #Z-0065-2019
Product Description
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
Details
- Recalling Firm
- Vision RT Ltd
- Units Affected
- 690 systens
- 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.
- Location
- London
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Vision RT Ltd. Units affected: 690 systens.
Why was this product recalled? ▼
RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 10, 2018. Severity: Moderate. Recall number: Z-0065-2019.
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