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U.S. Department of Health and Human Services

Class 2 Device Recall Precision Rxi

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 Class 2 Device Recall Precision Rxi see related information
Date Posted August 24, 2008
Recall Status1 Terminated on August 09, 2012
Recall Number Z-1564-2008
Recall Event ID 46807
510(K)Number K041605 
Product Classification Image-intensified x-ray, fluoroscopic system - Product Code JAA
Product GE Healthcare Precision RXi Digital Remote X-Ray Imaging R&F System. It is a remote R&F system consisting of a tilting table with integrated spot film device, 65 or 89 kW pulsing generator and high heat capacity X-Ray tube. The system can be configured to meet a wide variety of digital record and fluoroscopy exams for various clinical applications with either 32 cm or 40 cm image intensifier.
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Recalling Firm/
Manufacturer
GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-544-3894
For Additional Information Contact
262-544-3894
Manufacturer Reason
for Recall
GE Healthcare Precision RXi tilt joystick became stuck in the Trendelenburg direction causing the patient to slide off the table. Also recall conducted to investigate the possibility of accidentally activation of the remote console joystick where a fatal accident occurred on a non-GE Remote R&F System. .
FDA Determined
Cause 2
Device Design
Action Two letters "GE Product Safety Notification" dated 12/18/07 and 3/7/08, addressed to Hospital Administrators, Manager of Radiology and Radiologists, were sent to each consignee. Each letter addressed a separate safety issue. Letters described the affected product, safety instructions, corrective action and contact information. The joystick can become stuck causing unintentional motion of the tube. Field Modification Instructions (FMI 10802/10803) have been issued to the field to install additional warning labels on the patient table, install a protector for the console joystick and inspect and correct the clearance between the console joystick and its mounting location. If your facility has a Precision RXi or Precision e system manufactured before March 2007, a GE Healthcare Field Engineer will schedule a field visit to install the added joystick protection. This upgrade will be performed at no charge. If you have any questions/concerns regarding this issue, please contact your local GE Healthcare sales or service representative.
Quantity in Commerce 193
Distribution (USA) AK CO IL LA MA MI MS NC NJ NY PA SC TN UT VA WA WI (OUSA) BR CA MX AU C3 KR PH TW AE AT BE BF BG CM CY CZ DE ES FI FR GB GE GR GY HR HU IT LB LV MT NA NG PL PT RO RU SA SD SE SI SK SY TN TR UA YU ZA
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 = JAA and Original Applicant = GENERAL MEDICAL MERATE S.P.A.
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