Recall Z-1971-2011 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE Healthcare, LLC
Precision 500D X-ray systems with under-table collimator part number 5234960. The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
| Date | May 6, 2011 (initiated Jun 10, 2010) |
| Status | Terminated |
| Reason | Use of high force when moving the image carriage/IDD into forward/park position can cause changes to the mechanical alignment of the collimator blades and allow the blades to open wider than specified, consequently allowing radiation outside the permitted field without warning to the user. This issue manifests with symptoms wherein the user cannot fully close down the lateral blades. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE Healthcare sent an Importan Electronic Product Radiation Warning letter to customers. The letter discussed the product defect description and related hazards, affected product details, instructions, and product correction. The firm will send a GE Field Service Representative to visit each affected customer site to inspect and correct all potentially affected units in the field following the instructions in field modification instructions No: 10846. If you have any questions please call 800-437-1171. |
| Quantity | 440 US |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.