Radionuclide Radiation Therapy System Product The product is a… — Class II medical device recall Z-1561-2016
Terminated recall by Elekta, Inc., reported 2016-05-04, distributed nationwide. The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted
| Recall number | Z-1561-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2016-04-19 |
| Classified | 2016-04-22 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2021-07-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CL, CN, CZ, DE, EG, ES, FR, GB, GR, HK, ID, IN, IQ, IT, JO, JP, KR, MA, MX, MY, NL, NO, PH, PL, PT, RS, RU, SA, SE, TR, TW |
| Quantity | 217 |
Product
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
Reason for recall
The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame.
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-1561-2016. 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.