Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0065-2019 — 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

U.S. FDA — Device Enforcement · United Kingdom · 2018-08-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0065-2019
Date of alert: 2018-08-24
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: Vision RT Ltd
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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