GE Precision 500D Classical Radiographic-Fluoroscopic X-ray System. Model #2289299-2, with console computer and touch sc
FDA device recall Z-0369-2008 · posted 2008-09-04 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 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.
- Date initiated
- 2007-10-04
- Date posted
- 2008-09-04
- Date terminated
- 2012-08-09
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPEDIO 500D R&F X-RAY SYSTEM (K011624) | GE Medical Systems | 2001-06-08 |