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 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.

FDA Recall Z-0005-2010 · Posted 2010-01-20

Recalling FirmGe Healthcare
Recall StatusTerminated
Product CodeJAA
Date Initiated2009-08-12
Date Terminated2012-04-23
Product Quantity1411 units total

Reason for Recall

A software defect - may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. This will also cause the displayed air kerma rate and cumulative air kerma to be inaccurate.

Firm Action

An Important Electronic Product Radiation Warning letter will be sent to customers identifying the issues, interim solution, and permanent solution. Questions or concerns are to be directed to the GEHC OEC service team at 1-800-874-7378.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Nationwide and Canadian Distribution

Official Source

View FDA Recall →

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

↑