OEC 6800 Miniview — Class I medical device recall Z-2040-2012
Terminated recall by GE OEC Medical Systems, Inc, reported 2012-08-01. Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues th
| Recall number | Z-2040-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE OEC Medical Systems, Inc, Salt Lake City, UT, United States |
| Recall initiated | 2006-11-20 |
| Classified | 2012-07-24 |
| Reported by FDA | 2012-08-01 |
| Terminated | 2013-05-13 |
| Quantity | 1,933 units |
Product
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
Reason for recall
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 6800 Miniview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lock-up, incorrect image display, incorrect dose area calculated air kerma in "film mo
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-2040-2012. 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.