Recall Z-0369-2008 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE Healthcare
GE Precision 500D Classical Radiographic-Fluoroscopic X-ray System. Model #2289299-2, with console computer and touch screen fullly integrated. the GE Precision 500D Classical Radiographic-Fluoroscopic X-ray System is used to perform radiographic and fluoroscopic x-ray examinations.
| Date | Sep 4, 2008 (initiated Oct 4, 2007) |
| Status | Terminated |
| Reason | It was reported that when the GE Precision 500D foot pedal is repeatedly activated, a defect in the fluoro-timer will cause the dose measurement to report a higher value than was actually received by the patient. Patient will receive a lower dosage irradiation time which will result in indication of cumulative air kerma higher than that to which the patient was actually exposed. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | A customer letter "GE Healthcare Product Safety Notification" dated 10/4/07 was distributed to customers informing them of the safety issue. A Field Modification Instructions (FMI 10806) was issued to the field for the Precision 500D product to install a sofware upgrade to correct the issue. This correction was released in October 2007. |
| Quantity | 106 |
| Distribution | AL, AR, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, ITALY, Kuwait, Great Britan, Spain and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011624 | EXPEDIO 500D R&F X-RAY SYSTEM GE Medical Systems, Jun 8, 2001 |