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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64809

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 27, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Accuray Incorporated

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1155-2013
Recall number
Z-1155-2013
Initiated
March 27, 2013
Classification
Class II
Status
Terminated
Recalling firm
Accuray Incorporated
Quantity
16 devices are subject to correction.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model number: 025007

Distribution pattern

Worldwide Distribution - USA Nationwide including the states of: OH, MO. OK, CA and VA and the countries of: Finland, France, Luxembourg, Poland, Russia, Turkey and Japan.