Stereotactic Circular Collimator — Class II medical device recall Z-0138-2014
Terminated recall by Elekta, Inc., reported 2013-11-13, distributed nationwide. Potential for clinical errors.
| Recall number | Z-0138-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2013-07-23 |
| Classified | 2013-11-04 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2014-11-18 |
| Distributed | Nationwide (US) |
| Quantity | 89 |
Product
Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.
Reason for recall
Potential for clinical errors.
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-0138-2014. 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.