—#98273

Product

BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose Diagnostic Radiography.

FDA product code: IZO — Generator, High-Voltage, X-Ray, Diagnostic
Device class: Class 1
Medical specialty: Radiology
Affected lot / code info: 704031 / 70408

Why it was recalled

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 (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2011-01-17
Posted by FDA: 2011-03-04
Terminated: 2020-08-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98273. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.