| Class 2 Device Recall Monitor suspensions used with Advantix Legacy, RFX Classical, SFX90 | |
Date Initiated by Firm | March 09, 2007 |
Date Posted | October 27, 2008 |
Recall Status1 |
Terminated 3 on August 24, 2012 |
Recall Number | Z-0200-2009 |
Recall Event ID |
49581 |
510(K)Number | K760466 K801320 K931049 |
Product Classification |
Diagnostic x-ray high voltage generator - Product Code IZO
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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 WI 53188-1615
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For Additional Information Contact | 262-544-3894 |
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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = IZO 510(K)s with Product Code = IZO
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