FDA Device Recall Z-0005-2010: Ge Healthcare

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0005-2010.

Recall Res Number

Z-0005-2010

Recalling Firm / Manufacturer

Ge Healthcare

FEI Number

1720753

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2009-08-12

Date Posted

2010-01-20

Date Terminated

2012-04-23

Product Code

JAA

Event Number

53491

Product Quantity

1411 units total

Product Description GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.

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.

Action Details 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.

Distribution Pattern Nationwide and Canadian Distribution

Code Information / Serial Numbers All associated serial numbers

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Medical Device Recall: Z-0005-2010

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer