—#152295

Product

Brilliance iCT

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060937
Affected lot / code info: Rotor-4535-673-94382 SN 19, installed on Brilliance ICT System S/N 200203

Why it was recalled

During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.

Root cause (FDA determination)

Employee error

Action the firm took

Philips sent an Customer Information letter. A document showed an incorrect torque wrench used during the assembly process which could potentially apply 4 Newton-meters less torque than specified to the system rotor counterweight bolts. Out of an abundance of caution, Philips will have a Field Service Engineer ensure the bolts on your system are correctly torqued. If you need any further information or support concerning this issue, please contact your local Philips representative. For further information please call (440) 483-5777.

Recalling firm

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

Distribution

Distribution pattern: Product was not distributed in the US. Unit was distributed in Australia.

Timeline

Recall initiated: 2016-12-23
Terminated: 2018-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152295. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.