—#136899

Product

Brilliance iCT Computed Tomography X-ray system

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060937
Affected lot / code info: Model# 728306; Serial #'s: 85019 & 85023.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Internationally to the countries of China and Norway.

Timeline

Recall initiated: 2015-04-13
Posted by FDA: 2015-05-29
Terminated: 2015-10-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136899. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.