Monitor suspensions used with Advantx Legacy…

Date posted by the FDA

Oct. 27, 2008

Status

Terminated

Filed by

GE Healthcare

Product

Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, manufactured after March 8, 1985 for Advantx Legacy, RFX and SFX systems. General-purpose radiographic system component used to suspend the system's image monitor.

Reason

GE Healthcare has recently become aware of a potential risk of monitor dropping associated with the monitor suspension of the Advantx system that may impact patient safety. It has been reported that suspensions manufactured after March 8, 1995 did not have the required thread locking agent applied to the setscrew, allowing the setscrew to back out over time, which can lead to the monitor dropping

Distribution pattern

Worldwide Distribution --- USA including states of AZ, CA, FL, GA, IA, MD, MO, NC, NY, OH, OK, TN, TX,WI, and LA, and country of Slovak Republic.

Quantity

21

Codes and lots

00000486566WK3, 00000486586WK1, 00000486555WK6, 00000486573WK9, 00000486581WK2, 00000478555WK6, 00000486579WK6, 00000486588WK7, 00000486557WK2, 00000486560WK6, 00000486550WK7, 00000486556WK4, 00000486547WK3, 00000056366VP8, 00000486544WK0, 00000486541WK6, 00000486543WK2, 00000471291WK5, 00000486568WK9, and 00000486559WK8

Recall started

March 9, 2007

Device type

Generator, High-Voltage, X-Ray, Diagnostic

Root cause (FDA)

Component change control

What the company told customers

Consignees were sent a GE Healthcare "Product Safety Notification" letter dated September 13, 2007. The letter was addressed to Hospital Administrators/Managers of Radiology/Radiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Corrective Action and Contact Information. The letter recommends that customers move the monitor suspension to an open area in the room where viewing is still possible and make sure to minimize the movement of the monitor until a Qualified GE Healthcare Field Engineer has inspected the suspension. The letter also states that a Qualified GE Healthcare Field Engineer will schedule a field visit to inspect the monitor suspension. Customers should contact their sales or service rep is they have any questions.

Recall number

Z-0200-2009

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0200-2009. The agency record governs; check it and the company before acting.