Brilliance iCT 의 리콜

Recall

71231

Class 2

Z-1695-2015

2015-04-13

2015-05-29

Terminated

United States

2015-10-01

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136899

A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.

Philips sent an Urgent - Field Safety Notice dated April 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips Healthcare is recommending to stop the use of your system until the X-ray tube mounting fasteners are replaced. In addition, a Philips Field Service Engineer (FSE) will service your system via a Mandatory Field Change Order (FCO 72800638). A Philips FSE will contact you to schedule this appointment. If you need any further information or support concerning this issue, please contact your local Philips representative or your local Philips Healthcare office. This notice has been submitted to the appropriate Regulatory Agency. Philips apologizes for any inconveniences this problem has caused your organization. For further questions please call (440) 483-7600.