Z-0190-2015Class II

MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed...

Name: Z-0190-2015 MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2014-10-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-10-09 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of 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... on 2014-10-09. FDA classified it as Class II and gives the reason as ""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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0190-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-09
Posted: 2014-12-16
Terminated: 2015-07-02
Recalling firm: Philips North America LLC
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.
Product code: JAK System, X-Ray, Tomography, Computed
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
Root cause tag: software
FDA root 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0190-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0190-2015	Class II	Ongoing	Voluntary: Firm initiated	2014-11-19	2014-11-07

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)