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

Recall Z-1155-2013 — RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.

U.S. FDA — Device Enforcement · United States · 2013-03-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1155-2013
Date of alert: 2013-03-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Accuray Incorporated
Product category: device
Product type: Devices

Reported risk: A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.

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.

Recall Z-1155-2013 — RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.

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