Device Recall MX 16 Slice

  • Model / Serial
    Model #: 728131; Serial #s: 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, EP16E130077, EP16E130078, EP16E130079, EP16E130080, EP16E130082, EP16E130083, EP16E130086, EP16E130087, EP16E130088, EP16E130089, EP16E130092, EP16E130093, EP16E130094, EP16E130095, EP16E130097, EP16E130098, EP16E130099, EP16E130100, EP16E130102, EP16E130103, EP16E130105, EP16E130106, EP16E130107, EP16E130109, EP16E130110, EP16E140001, EP16E140002, EP16E140003, EP16E140007, EP16E140008, EP16E140009, EP16E140010, EP16E140011, EP16E140012, EP16E140014, EP16E140015, EP16E140016, EP16E140017, EP16E140018, EP16E140019, EP16E140021, EP16E140022, EP16E140024, EP16E140025, EP16E140027, EP16E140029, EP16E140035, EP16E140039, EP16E140041, EP16E140042, EP16E140050, EP16E140057, EP16E140059, EP16E140075, EP16EB110006, EP16EB120006, EP16EB120007, EP16EB120008, EP16EB120009, EP16EB130001, EP16EB130002, EP16EB130003, P16E090027 & P16EM09002
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.
  • Product Description
    MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Model #: 728132; Serial #s: EP16ER100003, EP16ER100004, EP16ER100005, EP16ER100007, EP16ER100008, EP16ER110003, EP16ER110005, EP16ER110006, EP16ER110007, EP16ER110008 & EP16ER110009.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.
  • Product Description
    MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
  • Manufacturer