Z-1638-2015Class II

GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)

Name: Z-1638-2015 GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
Creator: GE OEC Medical Systems, Inc
Published: 2014-05-22
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-05-22 / Terminated

FDA source

GE OEC Medical Systems, Inc began a recall of GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW) on 2014-05-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1638-2015
Classification: Class II
Status: Terminated
Initiated: 2014-05-22
Posted: 2015-06-08
Terminated: 2015-06-24
Recalling firm: GE Healthcare
Product: GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
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.
FDA root cause: Radiation Control for Health and Safety Act
Action: GE Healthcare Surgery Planned Action(s) to repair the defect or to bring the product into compliance: The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 9 units consisted of the following: 1. Replacing the tube side cover with the laser aimer assembly with a tube side cover without a laser aimer assembly. This correction brought the systems into compliance with applicable US regulations. For further questions please call (801) 536-4615.
Quantity in commerce: 9
Distribution: US Distribution to the states of: MD, NC, MT, NJ, UT and NY
Product codes and lots: OEC Brivo 865 Plus serial numbers B4S13061, B4S14006, B4S14007, B4S13033, B4S13032, B4S13038, B4S13039, B4S13024, AND B4S13023.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1638-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1638-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-08

Product code OXO

K123603Class IIOec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 PrimeGe Healthcare Surgery GE Oec Medical Systems, Inc. / cleared 2013-05-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)