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U.S. Department of Health and Human Services

Class 2 Device Recall Monitor suspensions used with Advantix Legacy, RFX Classical, SFX90

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 Class 2 Recall
Monitor suspensions used with Advantix Legacy, RFX Classical, SFX90
see related information
Date Posted October 27, 2008
Recall Status1 Open
Recall Number Z-0200-2009
Recall Event ID 49581
Premarket Notification
510(K) Numbers
K760466  K801320  K931049 
Product Classification Generator, High-Voltage, X-Ray, Diagnostic - Product Code IZO
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.
Code Information 00000486566WK3, 00000486586WK1, 00000486555WK6, 00000486573WK9, 00000486581WK2, 00000478555WK6, 00000486579WK6, 00000486588WK7, 00000486557WK2, 00000486560WK6, 00000486550WK7, 00000486556WK4, 00000486547WK3, 00000056366VP8, 00000486544WK0, 00000486541WK6, 00000486543WK2, 00000471291WK5, 00000486568WK9, and 00000486559WK8
Recalling Firm/
Manufacturer
GE Healthcare
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action 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.
Quantity in Commerce 21
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZO and Original Applicant = GE MEDICAL SYSTEMS
510(K)s with Product Code = IZO and Original Applicant = GENERAL ELECTRIC CO.
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