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

FDA device recall Z-0905-2011 · posted 2011-03-04 · Terminated

Recall details

Recalling firm

Philips Healthcare Inc.

Reason for recall

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.

Action taken

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

IZO

Quantity affected

1810 units in the US

Distribution

Worldwide Distribution

Date initiated

2011-01-17

Date posted

2011-03-04

Date terminated

2020-08-11

Location

Andover, MA