FDAClass IIJune 17, 2015

GE OEC Brivo 865 plus recall

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

Why was GE OEC Brivo 865 plus recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
Recalling firm
GE OEC Medical Systems, Inc
Quantity
9
Distribution
US Distribution to the states of: MD, NC, MT, NJ, UT and NY
Recall date
June 17, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls