Z-1565-2008

GE Healthcare Precision RXi version e Remote X-Ray Imaging R&F System. It is a remote analog R&F system...

Name: Z-1565-2008 GE Healthcare Precision RXi version e Remote X-Ray Imaging R&F System. It is a remote analog R&F system...
Creator: GE Healthcare
Published: 2007-12-18
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-12-18 / Terminated / root cause: design

FDA source

GE Healthcare began a recall of 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... on 2007-12-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1565-2008
Status: Terminated
Initiated: 2007-12-18
Posted: 2008-08-24
Terminated: 2012-08-09
Recalling firm: GE Healthcare
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.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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. .
Root cause tag: design
FDA root cause: 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: 6
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
Product codes and lots: 10805 10805 10805 10804 10804 10804

Product code JAA

K041605Class IIPrecision Rxi Analog X-Ray SystemGeneral Medical Merate S.P.A / cleared 2004-06-30

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)