Device Recall MX 16slice

  • Model / Serial
    System Code #, 728131, Serial #: EP16E090001-EP16E090004, EP16E090006-EP16E090015, EP16E100001- EP16E100004, EP16E100006, EP16E100008- EP16E100063, EP16E100067, EP16E100069- EP16E100113, EP16E110001- EP16E110065, EP16E110067-EP16E110070, EP16E110074-EP16E110075, EP16E110077-EP16E110078, EP16E110080, EP16E110083- EP16E110085, EP16E110088- EP16E110112, EP16E110115- EP16E110119, EP16E120001- EP16E120014, EP16E120016, EP16EB110003- EP16ER100007, EP16ER110003, EP16ER110006, P16C080001, P16C080002, P16C090001, P16C100001-P16C100015, P16C100017, P16C100018, P16C110001- P16C110008, P16C110011-P16C110037, P16C120001-P16C120003, P16C120006, P16C120007, P16E080005, P16E080007, P16E080008, P16E080012, P16E090002-P16E090021, P16E090024-P16E090028, P16E100002, P16EF80010, P16EM08003, and P16EM09002-P16EM09004.  System Code #, 728132, Serial #: EP16E100005, EP16E100007, EP16E110066, EP16ER100003-EP16ER100005, EP16ER100008, EP16ER110004, EP16ER110005, and EP16ER110007-EP16ER110024.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, Nationwide (US) including the states AL, AR, CA, FL, GA, IL, IN, MS, NJ, NV, NY, OH, PA, and VA and the countries of Albania, Argentina, Australia, Belgium, Brazil, Chile, China, Colombia, Dominican Republic, Ecuador, France, Germany, Greece, India, Indonesia, Ireland, Italy, Jordan, Lebanon, Malawi, Mexico, Nepal, Netherlands, Oman, Palestine, Philippines, Poland, Romania, Russia, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Turkey, Uganda, and Venezuela.
  • Product Description
    MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA

One device with a similar name

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  • Model / Serial
    Model # 728131  510(k) K083498  Serial #: EP16E090001, EP16E090002, EP16E090003, EP16E090006, EP16E090009, EP16E090010, EP16E090011, EP16E090012, EP16E090013, EP16E090015, EP16E100001, EP16E100004, EP16E100006, EP16E100008, EP16E100010, EP16E100012, EP16E100013, EP16E100016, EP16E100017, EP16E100018, EP16E100019, EP16E100020, EP16E100021, EP16E100022, EP16E100023, EP16E100024, EP16E100025, EP16E100026, EP16E100028, EP16E100029, EP16E100031, EP16E100032, EP16E100033, EP16E100034, EP16E100035, EP16E100037, EP16E100038, EP16E100039, EP16E100041, EP16E100043, EP16E100044, EP16E100045, EP16E100046, EP16E100047, EP16E100049, EP16E100051, EP16E100052, EP16E100055, EP16E100056, EP16E100058, EP16E100059, EP16E100060, EP16E100062, EP16E100063, EP16E100067, EP16E100069, EP16E100070, EP16E100071, EP16E100072, EP16E100073, EP16E100074, EP16E100075, EP16E100076, EP16E100077, EP16E100078, EP16E100079, EP16E100081, EP16E100082, EP16E100083, EP16E100084, EP16E100085, EP16E100086, EP16E100087, EP16E100088, EP16E100090, EP16E100091, EP16E100093, EP16E100094, EP16E100095, EP16E100096, EP16E100100, EP16E100101, EP16E100103, EP16E100104, EP16E100105, EP16E100106, EP16E100107, EP16E100108, EP16E100109, EP16E100110, EP16E100112, EP16E100113, EP16E110003, EP16E110005, EP16E110006, EP16E110009, EP16E110011, EP16E110012, EP16E110013, EP16E110014, EP16E110015, EP16E110017, EP16E110018, EP16E110019, EP16E110020, EP16E110021, EP16E110023, EP16E110024, EP16E110025, EP16E110026, EP16E110029, EP16E110030, EP16E110031, EP16E110035, EP16E110037, EP16E110038, EP16E110042, EP16E110043, EP16E110044, EP16E110045, EP16E110046, EP16E110047, EP16E110048, EP16E110049, EP16E110050, EP16E110051, EP16E110054, EP16E110055, EP16E110056, EP16E110058, EP16E110060, EP16E110063, EP16E110064, EP16E110066, EP16E110067, EP16E110069, EP16E110074, EP16E110075, EP16E110077, EP16E110078, EP16E110080, EP16E110083, EP16E110084, EP16E110085, EP16E110089, EP16E110090, EP16E110091, EP16E110092, EP16E110093, EP16E110095, EP16E110096, EP16E110097, EP16E110099, EP16E110100, EP16E110101, EP16E110102, EP16E110104, EP16E110105, EP16E110106, EP16E110107, EP16E110108, EP16E110109, EP16E110110, EP16E110111, EP16E110117, EP16E110119, EP16E120003, EP16E120004, EP16E120005, EP16E120006, EP16E120008, EP16E120009, EP16E120010, EP16E120011, EP16E120014, EP16E120015, EP16E120016, EP16E120017, EP16E120019, EP16E120021, EP16E120023, EP16E120024, EP16E120025, EP16E120026, EP16E120027, EP16E120029, EP16E120030, EP16E120031, EP16E120032, EP16E120033, EP16E120034, EP16E120035, EP16E120036, EP16E120037, EP16E120040, EP16E120041, EP16E120042, EP16E120043, EP16E120044, EP16E120045, EP16E120046, EP16E120047, EP16E120048, EP16E120050, EP16E120052, EP16E120055, EP16E120056, EP16E120058, EP16E120059, EP16E120060, EP16E120061, EP16E120063, EP16E120065, EP16E120067, EP16E120068, EP16E120070, EP16E120071, EP16E120072, EP16E120074, EP16E120075, EP16E120076, EP16E120078, EP16E120081, EP16E120083, EP16E120089, 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, P16C120011, P16C120012, P16C120014, P16C120016, P16C120017, P16C120018, P16C120019, P16C120020, P16C120021, P16C120022, P16C120023, P16C120024, P16C120025, P16C120026, P16C120027, P16C120029, P16C120030, P16C120032, P16C120033, P16C120036, P16C120038, P16C120039, P16E080007, P16E080008, P16E090002, P16E090003, P16E090004, P16E090007, P16E090008, P16E090012, P16E090013, P16E090014, P16E090015, P16E090016, P16E090018, P16E090019, P16E090027, P16EF80010, P16EM08003, P16EM09002 and P16EM09004.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including the states of AL, AR, CA, FL, GA, IL, IN, KY, MS, NC, NJ, NV, NY, OH, PA, and VA; and countries of: Albania, Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, China, Ghana, Greece, India, Indonesia, Ireland, Italy, Jordan, Latvia, Lebanon, Libya, Lithuania, Malawi, Mexico, Nepal, Netherlands, Oman, Palestine, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, Uganda, Ukraine, Uzbekistan, Venezuela and Vietnam.
  • Product Description
    MX 16-Slice CT Scanner System. || Used as a whole-body computed tomography X-Ray system.
  • Manufacturer