GE OEC Brivo 865 plus — Class II medical device recall Z-1638-2015
Terminated recall by GE OEC Medical Systems, Inc, reported 2015-06-17, distributed in MD, MT, NC, NJ, NY, UT. Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser produc
| Recall number | Z-1638-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE OEC Medical Systems, Inc, Salt Lake City, UT, United States |
| Recall initiated | 2014-05-22 |
| Classified | 2015-06-08 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2015-06-24 |
| Distributed | MD, MT, NC, NJ, NY, UT |
| Quantity | 9 |
| Serial numbers | B4S13023, B4S13024, B4S13032, B4S13033, B4S13038, B4S13039, B4S13061, B4S14006, B4S14007 |
| Model numbers | 520002DW |
Product
GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
Reason for recall
Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser product report and therefore do not comply with the US regulations for laser products.
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-1638-2015. 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.