Recall Z-1638-2015— GE OEC Medical Systems, Inc

Name: FDA recall Z-1638-2015
Creator: U.S. Food and Drug Administration
Published: 2014-05-22

Class II · Terminated

Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2014-05-22, terminated 2015-06-24. It names one FDA 510(k) clearance: K123603. 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..

Recalling firm: GE OEC Medical Systems, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-05-22
Terminated: 2015-06-24
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K123603 — OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIMEGe Healthcare Surgery GE Oec Medical Systems, Inc.·cleared 2013-05-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.