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Devices
Philips Healthcare Ingenuity Core 128 Computed Tomography Xray system
Model / Serial
Model No. 728323; S/N: 30016, 32012, 32013, 32016, 32024, 32028, 32033, 32036, 32041, 32046, 32048, 32050, 32051, 32052, 32053, 32054, 32055, 32056, 32058, 32059, 32062, 32063, 32064, 32068, 32069, 32070, 32072, 32073, 32074, 32075, 32077, 32078, 32079, 32081, 32082, 32083, 32084, 32086, 32087, 32089, 32092, 32093, 32095, 32097, 32098, 32099, 32100, 32102, 32103, 32104, 32105, 32106, 32108, 32110, 32113, 32114, 32115, 32116, 32119, 32120, 32122, 32123, 32124, 32125, 32128, 32129, 32131, 32132, 32133, 32134, 32135, 32136, 32137, 32138, 32140, 32141, 32145, 32146, 320003, 320006, 320018, 320024, 320029, 320030, 320033, 320037, 320054, 320058, 320069, 320073, 320078, 320079, 320090, 320092, 320099, 320114, 320115, 320123, 320125, 320126, 320128, 320133, 320134, 320138, 320146, 320200, 320201, 320202, 320203, 320204, 320205, 320208, 320212, 320217, 320219, 320220, 320222, 320223, 320224, 320225, 320226, 320228, 320231, 320232, 320239, 320241, 320243, 320246, 320247, 336013, 336015, 336016, 336018, 336027, 336029, 336034, 336046, 336059, 336060, 336064, 336066, 336068, 336071, 336072, 336073, 336075, 336078, 336079, 336080, 336081, 336083, 336084, 336085, 336086, 336087, 336088, 336089, 336091, 336092, 336095, 336097, 336098, 336099, 336105, 336107, 336108, 336110, 336111, 336112, 336113, 336115, 336116, 336117, 336119, 336120, 336121, 336122, 336123, 336126, 336128, 336131, 336132, 336133, 336135, 336137, 336138, 336139, 336140, 336143, 336144, 336145, 336147, 336148, 336150 & 336151.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
Product Description
Ingenuity Core 128 Computed Tomography X-ray system
Manufacturer
Philips Medical Systems (Cleveland) Inc
1 Event
Recall of Philips Healthcare Ingenuity Core 128 Computed Tomography Xray system
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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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