RoboCouch Patient Positioning System Product Usage: is intended for… — Class II medical device recall Z-1155-2013
Terminated recall by Accuray Incorporated, reported 2013-05-01, distributed nationwide. A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the Ro
| Recall number | Z-1155-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accuray Incorporated, Sunnyvale, CA, United States |
| Recall initiated | 2013-03-27 |
| Classified | 2013-04-19 |
| Reported by FDA | 2013-05-01 |
| Terminated | 2013-08-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | FI, FR, JP, LU, PL, RU, TR |
| Quantity | 16 devices |
| Model numbers | 025007 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1155-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.