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Devices
Device Recall Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiolog
Model / Serial
Brilliance CT 16: Model Number: 728246; Serial Number: 5314, 6719, 6726, 6727, 6728, 6729, 6730, 6731, 6732, 6734, 6735, 6736, 6737, 6738, 6744, 6746, 6747, 6748, 6749, 6750, 6751, 6752, 6753, 6754, 6756, 6757, 6758, 6759, 6760, 6761, 6762, 6764, 6767, 6768, 6772, and 50213. Brilliance CT 64: Model Number: 728231; Serial Number: 10805, 10806, 90047, 95880, 95881, 95882, 95885, 95892, 95903, 95907, 95910, 95912, 95913, 95914, 95915, 95918, 95920, 95921, 95922, and 98895. Brilliance CT Big Bore Oncology: Model Number: 728243; Serial Number: 7971, 7977, 7980, 7989, and 7994. Brilliance CT Big Bore Radiology: Model Number: 728244; Serial Number: 7957, 7965, 7979, and 7985. Brilliance iCT: Model Number: 728306; Serial Number: 100477, 100483, 100487, 100489, 100491, 100492, 100494, 100495, 100496, 100500, 100502, 100504, and 100507. Ingenuity CT: Model Number: 728326; Serial Number: 300165 and 333013. Ingenuity Core: Model Number: 728321; Serial Number: 310138, 310142, 310144, 310145, 310149, 310151, 310152, 310153, 310154, 310155, 310158, 310160, 310161, 310162, 310163, 310164, 333013, 333015, and 333017. Ingenuity Core128: Model Number: 728323; Serial Number: 320113, 320114, 320116, 320117, 320118, 320120, 320121, 320122, 320124, 320125, 320128,320129, 320130, 320134, 320137, 320138, 320139, 320140, 320141, 320142, 320143, 320144,320145, 320146, 320147, 320148, 336009, 336010, 336011, 336012, 336013, 336015, 336016, 336018, and 336023. Ingenuity Flex: Model Number: 728317; Serial Number: 345005
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution - USA including the states of CA, FL, IL, IN, KY, MD,SC, and TX.
Product Description
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.
Manufacturer
Philips Medical Systems (Cleveland) Inc
1 Event
Recall of Device Recall Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiolog
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Manufacturer
Philips Medical Systems (Cleveland) Inc
Manufacturer Address
Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
Manufacturer Parent Company (2017)
Philips
Source
USFDA
Language
English
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