Class 2 Device Recall Philips Healthcare MX 16slice CT Scanner System and MX 16slice CT Scanner System Phase 11

• Date Initiated by Firm: October 09, 2014
• Date Posted: December 16, 2014
• Recall Status: Terminated on July 02, 2015
• Recall Number: Z-0190-2015
• Recall Event ID: 69473
• 510(K)Number: K083498 K091195
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: Daniel Brown; 440-483-7600
• Manufacturer Reason for Recall: "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
• FDA Determined Cause: Software Design Change
• Action: Philips is informing the consignees of this issue through a Field Safety Notice (FSN) 72800615 on October 09, 2014. The US consignees will receive this notice via certified mail and Philips Key Market representatives will distribute the FSN internationally. Additionally, A Field Service Engineer will contact each site to schedule a time to install the software update.
• Quantity in Commerce: 708
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JAK