Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1638-2015 · Posted 2015-06-08

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeOXO
Date Initiated2014-05-22
Date Terminated2015-06-24
Product Quantity9

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.

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123603OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIMEGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2013-05-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑