Elekta — Class II medical device recall Z-0885-2013
Terminated recall by Elekta, Inc., reported 2013-03-06, distributed nationwide. If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view
| Recall number | Z-0885-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2013-01-18 |
| Classified | 2013-02-26 |
| Reported by FDA | 2013-03-06 |
| Terminated | 2014-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
Product
Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
Reason for recall
If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.
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-0885-2013. 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.