FDA-Device2014-04-23Class II
Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.
Philips Medical Systems (Cleveland) Inc
Hazard
Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. As a result, the table top can become free floating due to the disengaged service latch in the table tops subframe.
Sold states
Nationwide Distribution - USA including the states of CA, FL, IL, IN, KY, MD,SC, and TX.
Affected count
135
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1461-2014Don't want to check this manually?
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