The Recall Desk

FDA (Devices) recall action 82664

Accuray Incorporated recalled 2 products on 2019-06-12

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-06-12
Critical
0
Units
111

Why these products were recalled

There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2019-06-12

    Accuray Recalls CyberKnife M6 Systems Due to Collimator Housing Drop Risk

    Accuray is recalling 68 CyberKnife M6 systems because an interlock interruption during automated housing exchange can cause the secondary collimator housing to drop.

    Product
    CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: Cyb
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-06-12

    Accuray CyberKnife VSI Robotic Radiosurgery Systems Recalled for Collimator Housing Drop

    Accuray is recalling 43 CyberKnife VSI systems because an interlock interruption during automated housing exchange can cause the secondary collimator housing to drop.

    Product
    CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System
    Category
    Distribution
    0 states