Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Lega

FDA device recall Z-0804-2014 · posted 2014-01-21 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were missing since installation of the system. GE is not aware of any fall of the overhead monitor suspension.

Action taken

GE Healthcare Systems sent an " Urgent Medial Device Correction" letter dated November 7, 2013. The letter was addressed to Hospital Administrators / Risk Mangers, Managers of Radiology /Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (USA 800-437-1171, Japan 0120-055-919, For other countries, please contact your local GE Healthcare Service Representative).

Root cause

Employee error

Status

Terminated

Product code

JAA

Quantity affected

5651

Distribution

Worldwide Distribution - US Nationwide including Washington D.C., Guam, and Puerto Rico. Outside the US to include: Afghanistan, Algeria, Argentina, Australia, Austria, Azerbaijan, Belarus, Belgium, B

Date initiated

2013-11-08

Date posted

2014-01-21

Date terminated

2014-11-03

Location

Waukesha, WI

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