FDAAugust 24, 2018device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
What to do
FDA enforcement status: Terminated
Brands named
vision rtvision
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAThe AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.2025-08-27
- FDAEverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH2022025-08-18
- FDACorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m2025-08-18
- FDAACUVUE¿ OASYS MAX 1-Day MULTIFOCAL2025-06-12
- FDACorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only2024-10-16
- FDAJohnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.2024-03-14
- FDATECNIS Toric II OptiBlue IOL Models ZCW2023-12-12
- FDATECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only2023-07-06
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