Class 2 Device Recall Precision Rxi
|Date Initiated by Firm
||December 18, 2007
|Date Posting Updated
||August 24, 2008
||Terminated 3 on August 09, 2012
|Recall Event ID
||Image-intensified x-ray, fluoroscopic system - Product Code JAA
||GE Healthcare Precision RXi 23A/ 32A Remote X-Ray Imaging R&F System. It is a remote analog R&F system consisting of a tilting table with integrated spot film device, 65 kW pulsing generator and high heat capacity X-Ray tube. The system can be configured to meet a wide variety of exams for various clinical applications with ether 23 cm image intensifier with 512x512 Image Chain or 32 cm Image intensifier with either 512x512 Image Chain or 1Kx 1K Image Chain.
||101, 103, 117, 121, 128, 132, 133, 135, 136, 152, 156, 160, 162, 164, 173, 178, 182, 184, 190, 194, 196, 201, 202, 209, 221, 228, 232, 235, 238, 240, 246, 250, 251, 252, 254, 259, 260, 261, 263, 264, 267, 268, 273, 275, 276, 281, 283, 289, 295, 297, 300, 302, 310, 322, 330, 331, 333, 342, 343, 347, 348, 351, 353, 354, 365, 367.
| GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
|For Additional Information Contact
|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. .
||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
|Total Product Life Cycle
TPLC Device Report
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.
||510(K)s with Product Code = JAA and Original Applicant = GENERAL MEDICAL MERATE S.P.A.