Brilliance 40, Model 728235 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 Recall Z-0544-2019 · Posted None
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Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2018-10-18
Date Terminated2021-08-03
Product Quantity6,343 units in total
Reason for Recall
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
Firm Action
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.
Root Cause
Process control
Distribution Pattern
US Nationwide Distribution
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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