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.
FDA Recall Z-0369-2008 · Posted 2008-09-04
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Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeJAA
Date Initiated2007-10-04
Date Terminated2012-08-09
Product Quantity106
Reason for Recall
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.
Firm 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.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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