—#168981

Product

Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K012009
Affected lot / code info: System Serial Number: 2598 3008 3098 4001 4002 4003 4005 4006 4007 4008 4009 4010 4011 4012 4014 4015 4016 4020 4021 4022 4023 4026 4027 4028 4029 4030 4031 4032 4033 4034 4035 4039 4040 4044 4045 4047 4048 4049 4050 4052 4053 4054 4056 4058 4059 4061 4062 4063 4064 4065 4066 4067 30099 40004 40005 40006 40007 40008 40009 40010 40011 40012 40014 40015 40016 40018 40019 40020 40021 40023 40025 40028 40029 40031 40032 40034 62986554 4008/6086 4039/7128 728251_859-1766

Why it was recalled

There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall

Root cause (FDA determination)

Process control

Action the firm took

On October 18, 2018, Philips notices to their customers via courier service. Customers were advised to take the following actions: If any unusual noise is heard, discontinue use of the system immediately and contact your Philips representative for support. Field Order Change (FCO) 72800703 will be deployed to initiate an inspection of the front gantry cover. If the inspection finds evidence of weakening at this connection point, a temporary repair solution will be put in place to secure the cover for continued system use. FCO 72800704 will then be deployed to replace the affected front cover. A Philips Field Service Engineer will contact you to schedule the inspection of your system. Customers in need of further information or support concerning this issue, please contact your local Philips representative (North America & Canada) 1-800-722-9377.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2018-10-18
Terminated: 2021-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168981. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.