CyberKnife Treatment Delivery System — Class II medical device recall Z-1272-2021
Terminated recall by Accuray Incorporated, reported 2021-03-24, distributed nationwide. The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time al
| Recall number | Z-1272-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accuray Incorporated, Madison, WI, United States |
| Recall initiated | 2021-02-26 |
| Classified | 2021-03-17 |
| Reported by FDA | 2021-03-24 |
| Terminated | 2022-06-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BG, BR, CA, CH, CL, CN, CO, CR, DE, ES, FR, GB, GR, HK, HU, IE, IN, IT, JP, KR, LU, LV, MX, MY, OM, PK, PL, PT, SA, SK, TH, TR, TW |
| Quantity | 243 units |
| Serial numbers | C0008, C0014, C0022, C0040, C0042, C0046, C0047, C0056, C0059, C0063, C0064, C0066, C0067, C0071, C0074, C0076, C0077, C0079, C0085, C0086, C0089, C0090, C0091, C0092, C0093 and 218 more |
Product
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Reason for recall
The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
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-1272-2021. 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.