Precise Digital Accelerator Delivery of radiation to defined target… — Class II medical device recall Z-2405-2012
Terminated recall by Elekta, Inc., reported 2012-09-26, distributed nationwide. There have been a small number of instances in hospitals where the joint between the drive gear and the gantry
| Recall number | Z-2405-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Norcross, GA, United States |
| Recall initiated | 2012-08-06 |
| Classified | 2012-09-19 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2014-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 110 |
Product
Precise Digital Accelerator Delivery of radiation to defined target volumes
Reason for recall
There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.
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-2405-2012. 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.