Brilliance iCT Computed Tomography X-ray system
FDA Recall Z-1695-2015 · Posted 2015-05-29
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Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2015-04-13
Date Terminated2015-10-01
Product Quantity2
Reason for Recall
A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Internationally to the countries of China and Norway.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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