Device Recall BuckyDiagnost with Optimus Generator 의 리콜

Recall

58077

Class 2

Z-0905-2011

2011-01-17

2011-03-04

Completed

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98273

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.

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) to resolve the issue by updating the system software free of charge. Philips will contact customers to implement the FCO. Further information or support concerning this issue can be obtained by contacting your local Philips representative. The Field Service Engineers began software implementation the week of March 21, 2011.