FDA Device recall Z-1638-2015
GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
- FDA Device
- Class II
- terminated
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class II recall of GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW) by Ge Oec Medical Systems, citing 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 lase….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1638-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-22 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Oec Medical Systems |
| Distribution | MD, MT, NC, NJ, NY, UT |
Product
GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
Reason
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.
Identifiers
| code_info | OEC Brivo 865 Plus serial numbers B4S13061, B4S14006, B4S14007, B4S13033, B4S13032, B4S13038, B4S13039, B4S13024, AND B4S13023. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1638-2015%22
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