Recall Z-0905-2011 ยท IZO Generator, High-Voltage, X-Ray, Diagnostic
Philips Healthcare Inc.
BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose Diagnostic Radiography.
| Date | Mar 4, 2011 (initiated Jan 17, 2011) |
| Status | Terminated |
| Reason | Affected systems were determined not to prevent run-on of a selected technique factor if the technique selector and the exposure control were activated simultaneously. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | A Customer Information BuckyDiagnost Diagnostic X-Ray System letter, dated January 6, 2011, was sent to customers. The letter identifies the affected product, the reason for the recall, actions that are to be taken by customers, and actions that are planned by the firm. Customers are advised to make sure that the desired exposure values are displayed and that they have released the technique button BEFORE they start the exposure by pressing the exposure switch whenever manually changing the exposure parameters and in order to avoid the problem. Philips will issue a Field Change Order (FCO) |
| Quantity | 1810 units in the US |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.