MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients. Access Dual CT system can be used as a Head and Whole Body Computed Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multi-slice capability. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles.
Enforcement
- Recall Number
- Z-0190-2015
- Event ID
- 69473
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips Medical Systems (Cleveland) Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 19, 2014
- Initiation Date
- October 9, 2014
- Classification Date
- November 7, 2014
- Termination Date
- July 2, 2015
- Address
- 595 Miner Rd, Cleveland, OH, 44143-2131, United States
Description
MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients. Access Dual CT system can be used as a Head and Whole Body Computed Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multi-slice capability. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles.
"The orientation of images is displayed incorrectly. When operator chooses gantry on the right side from operation console, and the patient position is HFDL, HFDR, FFDL or FFDR, the patient position picture and text is not consistent. "L" and "R" of scan images are reversed and this is not consistent with the patient actual position. "When a surview which is longe
Model Number: 728131, Serial Number(s): EP16E090001,EP16E090002,EP16E090003,EP16E090004,EP16E090006,EP16E090007,EP16E090008, EP16E090009,EP16E090010,EP16E090011,EP16E090012,EP16E090013,EP16E090015,EP16E100001, EP16E100004,EP16E100005,EP16E100006,EP16E100007,EP16E100008,EP16E100010,EP16E100011, EP16E100012,EP16E100013,EP16E100015,EP16E100016,EP16E100017,EP16E100018, EP16E100019,EP16E100020,EP16E100021,EP16E100022,EP16E100023,EP16E100024,EP16E100025, EP16E100026,EP16E100027,EP16E100028,EP16E100029,EP16E100030,EP16E100031,EP16E100032, EP16E100033,EP16E100034,EP16E100035,EP16E100036,EP16E100037,EP16E100038,EP16E100039, EP16E100041,EP16E100043,EP16E100044,EP16E100045,EP16E100046,EP16E100047,EP16E100048, EP16E100049,EP16E100051,EP16E100052,EP16E100055,EP16E100056,EP16E100057,EP16E100058, EP16E100059,EP16E100060,EP16E100061,EP16E100062,EP16E100063,EP16E100067,EP16E100069, EP16E100070,EP16E100071,EP16E100072,EP16E100073,EP16E100074,EP16E100075,EP16E100076, EP16E100077,EP16E100078,EP16E100079,EP16E100080,EP16E100081,EP16E100082,EP16E100083, EP16E100084,EP16E100085,EP16E100086,EP16E100087,EP16E100088,EP16E100090,EP16E100091, EP16E100092,EP16E100093,EP16E100094,EP16E100095,EP16E100096,EP16E100099,EP16E100100, EP16E100101,EP16E100102,EP16E100103,EP16E100104,EP16E100105,EP16E100106,EP16E100107, EP16E100108,EP16E100109,EP16E100110,EP16E100111,EP16E100112,EP16E100113,EP16E110003, EP16E110005,EP16E110006,EP16E110007,EP16E110009,EP16E110011,EP16E110012,EP16E110013, EP16E110014,EP16E110015,EP16E110017,EP16E110018,EP16E110019,EP16E110020,EP16E110021, EP16E110023,EP16E110024,EP16E110025,EP16E110026,EP16E110027,EP16E110028,EP16E110029, EP16E110030,EP16E110031,EP16E110032,EP16E110033,EP16E110034,EP16E110035,EP16E110037, EP16E110038,EP16E110039,EP16E110042,EP16E110043,EP16E110044,EP16E110045,EP16E110046, EP16E110047,EP16E110048,EP16E110049,EP16E110050,EP16E110051,EP16E110052,EP16E110054, EP16E110055,EP16E110056,EP16E110057,EP16E110058,EP16E110060,EP16E110062,EP16E110063, EP16E110064,EP16E110066,EP16E110067,EP16E110069,EP16E110070,EP16E110074,EP16E110075, EP16E110077,EP16E110078,EP16E110083,EP16E110085,EP16E110089,EP16E110090,EP16E110091, EP16E110092,EP16E110093,EP16E110095,EP16E110096,EP16E110097,EP16E110099,EP16E110100, EP16E110101,EP16E110102,EP16E110104,EP16E110105,EP16E110106,EP16E110108,EP16E110109, EP16E110110,EP16E110111,EP16E110115,EP16E110117,EP16E110118,EP16E110119,EP16E120003, EP16E120004,EP16E120005,EP16E120006,EP16E120007,EP16E120008,EP16E120009,EP16E120010, EP16E120011,EP16E120014,EP16E120015,EP16E120016,EP16E120017,EP16E120019,EP16E120021, EP16E120023,EP16E120024,EP16E120025,EP16E120026,EP16E120027,EP16E120029,EP16E120030, EP16E120031,EP16E120032,EP16E120033,EP16E120034,EP16E120035,EP16E120036,EP16E120037, EP16E120039,EP16E120041,EP16E120042,EP16E120043,EP16E120044,EP16E120045,EP16E120046, EP16E120047,EP16E120048,EP16E120050,EP16E120051,EP16E120052,EP16E120054,EP16E120055, EP16E120056,EP16E120058,EP16E120059,EP16E120060,EP16E120061,EP16E120063,EP16E120065, EP16E120067,EP16E120070,EP16E120071,EP16E120072,EP16E120074,EP16E120075,EP16E120076, EP16E120078,EP16E120081,EP16E120083,EP16E120088,EP16E120090,EP16E120091,EP16E120092, EP16E120093,EP16E120095,EP16E120096,EP16E120097,EP16E120098,EP16E120099,EP16E120100, EP16E120101,EP16E120102,EP16E120104,EP16E120105,EP16E120109,EP16E120110,EP16E120111, EP16E120113,EP16E120117,EP16E120118,EP16E120120,EP16E120121,EP16E120122,EP16E120123, EP16E120124,EP16E120125,EP16E120127,EP16E120128,EP16E120129,EP16E120130,EP16E130002, EP16E130003,EP16E130004,EP16E130005,EP16E130006,EP16E130007,EP16E130009,EP16E130010, EP16E130012,EP16E130013,EP16E130014,EP16E130015,EP16E130016,EP16E130017,EP16E130020, EP16E130021,EP16E130022,EP16E130023,EP16E130025,EP16E130026,EP16E130027,EP16E130029, EP16E130030,EP16E130031,EP16E130033,EP16E130034,EP16E130035,EP16E130036,EP16E130037, EP16E130040,EP16E130041,EP16E130042,EP16E130043,EP16E130044,EP16E130045,EP16E130046, EP16E130047,EP16E130048,EP16E130049,EP16E130050,EP16E130051,EP16E130052,EP16E130053, EP16E130055,EP16E130056,EP16E130057,EP16E130058,EP16E130062,EP16E130063,EP16E130064, EP16E130065,EP16E130066,EP16E130067,EP16E130068,EP16E130069,EP16E130070,EP16E130071, EP16E130072,EP16E130073,EP16E130074,EP16E130075,EP16E130076,EP16E130077,EP16E130078, EP16E130079,EP16E130080,EP16E130081,EP16E130082,EP16E130083,EP16E130086,EP16E130087, EP16E130088,EP16E130089,EP16E130091,EP16E130092,EP16E130093,EP16E130094,EP16E130095, EP16E130097,EP16E130098,EP16E130099,EP16E130100,EP16E130101,EP16E130102,EP16E130103, EP16E130105,EP16E130106,EP16E130107,EP16E130109,EP16E130110,EP16E140001,EP16E140002, EP16E140003,EP16E140006,EP16E140007,EP16E140008,EP16E140009,EP16E140010,EP16E140011, EP16E140012,EP16E140013,EP16E140014,EP16E140015,EP16E140016,EP16E140017,EP16E140018, EP16E140019,EP16E140021,EP16E140022,EP16E140023,EP16E140024,EP16E140025,EP16E140026, EP16E140027,EP16E140028,EP16E140029,EP16E140030,EP16E140031,EP16E140032,EP16E140033, EP16E140041,EP16EB110003,EP16EB110004,EP16EB110005,EP16EB110006,EP16EB120006, EP16EB120007, EP16EB120008, EP16EB120009, EP16EB130001, EP16EB130002, EP16EB130003, EP16EB130004, EP16EB130005, EP16EB130006, EP16EB130007, EP16EB130008, EP16EB130009, EP16EB130010, EP16EB130011, EP16EB130012, EP16EB130013, EP16EB130014, EP16EB130015, EP16EB130016, EP16EB130017, EP16EB130018, EP16EB130019, EP16EB130020, EP16EB130021, EP16EB140001, EP16EB140002, P16C080001, P16C080002, P16C100001, P16C100002, P16C100003, P16C100004, P16C100005, P16C100007, P16C100008, P16C100009, P16C100010, P16C100011, P16C100012, P16C100013, P16C100014, P16C100015, P16C100017, P16C100018, P16C110001, P16C110002, P16C110003, P16C110004, P16C110005, P16C110006, P16C110007, P16C110008, P16C110011, P16C110012, P16C110013, P16C110014, P16C110015, P16C110016, P16C110017, P16C110018, P16C110019, P16C110020, P16C110021, P16C110022, P16C110023, P16C110024, P16C110025, P16C110026, P16C110027, P16C110028, P16C110029, P16C110030, P16C110031, P16C110032, P16C110033, P16C110034, P16C110035, P16C110036, P16C110037, P16C120001, P16C120002, P16C120003, P16C120006, P16C120007, P16C120008, P16C120009, P16C120010, P16C120011, P16C120012, P16C120014, P16C120015, P16C120016, P16C120017, P16C120018, P16C120019, P16C120020, P16C120021, P16C120022, P16C120023, P16C120024, P16C120025, P16C120026, P16C120027, P16C120028, P16C120029, P16C120030, P16C120031, P16C120032, P16C120033, P16C120034, P16C120035, P16C120036, P16C120037, P16C120038, P16C120039, P16C120040, P16C120041, P16C120042, P16C120043, P16C120044, P16C120045, P16C120046, P16C120047, P16C120048, P16C120049, P16C120050, P16C120051, P16C130001, P16C130002, P16C130003, P16C130004, P16C130005, P16C130006, P16C130007, P16C130008, P16C130009, P16C130010, P16C130011, P16C130012, P16C130013, P16C130014, P16C130015, P16C130016, P16C130017, P16C130018, P16C130019, P16C130020, P16C130021, P16C130023, P16C130024, P16C130025, P16C130026, P16C130027, P16C130028, P16C130029, P16C130030, P16C130031, P16C130032, P16C130033, P16C130034, P16C130035, P16C130036, P16C130037, P16C130038, P16C130039, P16C130041, P16C130043, P16C130044, P16C130045, P16C130046, P16C130047, P16C130048, P16C130049, P16C130050, P16C130051, P16C130052, P16C130053, P16E080005, P16E080007, P16E080008, P16E090002, P16E090003, P16E090004, P16E090005, P16E090006, P16E090007, P16E090008, P16E090009, P16E090010, P16E090011, P16E090012, P16E090013, P16E090014, P16E090015, P16E090016, P16E090017, P16E090018, P16E090019, P16E090020, P16E090021, P16E090024, P16E090025, P16E090026, P16E090027, P16E090028, P16EF80010, P16EM08003, P16EM09002, P16EM09003, P16EM09004, P16EVO130002, P16EVO130003, P16EVO140001, P16EVO140002, P16EVO140003, P16EVO140005, P16EVO140006, P16EVO140007, P16EVO140008 Model Number: 728132, Serial Number(s): EP16ER100003,EP16ER100004,EP16ER100005,EP16ER100007,EP16ER100008,EP16ER110003, EP16ER110004,EP16ER110005,EP16ER110006,EP16ER110007,EP16ER110008,EP16ER110009, EP16ER110010,EP16ER110011,EP16ER110012,EP16ER110013,EP16ER110014,EP16ER110015, EP16ER110016,EP16ER110017,EP16ER110018,EP16ER110019,EP16ER110020,EP16ER110021, EP16ER110022,EP16ER110023,EP16ER110024,EP16ER120001,EP16ER120002,EP16ER120003, EP16ER120004,EP16ER120005,EP16ER120006,EP16ER120007,EP16ER120008,EP16ER120009, EP16ER120010,EP16ER120011,EP16ER120012,EP16ER120013,EP16ER120015,EP16ER120016, EP16ER120017,EP16ER120018,EP16ER130001,EP16ER130002,EP16ER130003,EP16ER130004, EP16ER130005,EP16ER130006,EP16ER130007,EP16ER130008,EP16ER130009,EP16ER130010, EP16ER130011,EP16ER130012,EP16ER130013,EP16ER130014,EP16ER130015,EP16ER130016, EP16ER130017,EP16ER130018,EP16ER130019,EP16ER130020,EP16ER130021,EP16ER130022, EP16ER130023,EP16ER130024,EP16ER130025,EP16ER130026,EP16ER130027,EP16ER130028, EP16ER130029,EP16ER130030,EP16ER130031,EP16ER130032,EP16ER130033,EP16ER130034
Domestic Distribution: AR, CA, FL, GA, IL, IN, KY, MI, MS, NC, ND, NJ, NV, NY, OH, PA, PR, SC, TN, and VA. Foreign distribution: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Chile, China, Colombia, Congo, Ecuador, Egypt, France, Germany, Ghana, Greece, Gutamala, Hungray, India, Indonesia, Ireland, Italy, Japan, Jordan, Latvia, Lybyan Arab JHamahiri, Lithuania, Malawi, Mexico, Myanmar, Namibia, Nepal, Netherlands, Oman, Palestine, Paraguay, Philippines, Poland, Portugal, Romania,Russia, Rwanda, Saudi Arabia, Senegal, South Agrica, South ZKorea, Spain, Sri Lanka, Switzerland, Tunisia, Turkey, Uganda, UAE, Venezuela, Vietnam, Zambia.
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