Z-0200-2009

Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, manufactured after...

Name: Z-0200-2009 Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, manufactured after...
Creator: GE Healthcare
Published: 2007-03-09
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-03-09 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare began a recall of Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, manufactured after March 8, 1985 for Advantx Legacy, RFX and SFX... on 2007-03-09. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0200-2009
Status: Terminated
Initiated: 2007-03-09
Posted: 2008-10-27
Terminated: 2012-08-24
Recalling firm: 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.
Product code: IZO Generator, High-Voltage, X-Ray, Diagnostic
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
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 00000486566WK3, 00000486586WK1, 00000486555WK6, 00000486573WK9, 00000486581WK2, 00000478555WK6, 00000486579WK6, 00000486588WK7, 00000486557WK2, 00000486560WK6, 00000486550WK7, 00000486556WK4, 00000486547WK3, 00000056366VP8, 00000486544WK0, 00000486541WK6, 00000486543WK2, 00000471291WK5, 00000486568WK9, and 00000486559WK8

Product code IZO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)