GE Healthcare GE Healthcare Precision RXi version e 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, and 50KW or 65 kW pulsing generator. The system is configured with a 23 cm image intensifier and a 512x512 Image Chain. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Healthcare Precision RXi version e 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, and 50KW or 65 kW pulsing generator. The system is configured with a 23 cm image intensifier and a 512x512 Image Chain.
Brand
GE Healthcare
Lot Codes / Batch Numbers
10805 10805 10805 10804 10804 10804
Products Sold
10805 10805 10805 10804 10804 10804
GE Healthcare is recalling GE Healthcare Precision RXi version e Remote X-Ray Imaging R&F System. It is a remote analog R&F s due to GE Healthcare Precision RXi tilt joystick became stuck in the Trendelenburg direction causing the patient to slide off the table. Also recall conducte. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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. .
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AK, CA, CO, DE, IL, LA, MA, MI, MS, MT, NJ, NY, NC, PA, SC, SD, TN, UT, VA, WA, WI
Page updated: Jan 10, 2026