GE OEC Medical Systems, Inc: Medical Device Recall in 2015 - (Recall #: Z-1638-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 22, 2014

Date Posted: June 17, 2015

Recall Number: Z-1638-2015

Event ID: 71298

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.

Status: Terminated

Product Quantity: 9

Code Information:

OEC Brivo 865 Plus serial numbers B4S13061, B4S14006, B4S14007, B4S13033, B4S13032, B4S13038, B4S13039, B4S13024, AND B4S13023.

Distribution Pattern:

US Distribution to the states of: MD, NC, MT, NJ, UT and NY

Voluntary or Mandated:

Voluntary: Firm initiated