Precise Digital Accelerator Intended to be used for radiation therapy… — Class II medical device recall Z-1088-2015
Terminated recall by Elekta, Inc., reported 2015-02-18, distributed in AZ, CA, FL, KS, LA, MN, MO, NC…. Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.
| Recall number | Z-1088-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2015-01-07 |
| Classified | 2015-02-10 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2016-04-14 |
| Distributed | AZ, CA, FL, KS, LA, MN, MO, NC, NY |
| Countries outside the US | AT, BG, CA, CN, DE, ES, HU, IT, MT, MY, NL, NO, RU, SE, TW, UA |
| Quantity | 46 |
| Reason classes | device malfunction |
Product
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Reason for recall
Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.
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-1088-2015. 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.