Events

Recall of Device Recall Nuclear, Magnetic Resonance Imaging

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Electronics North America Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79451
  • Event Risk Class
    Class 2
  • Event Number
    Z-1435-2018
  • Event Initiated Date
    2018-03-16
  • Event Date Posted
    2018-04-18
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162722
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Reason
    Potential risk for helium gas inside the mr examination room during a magnet quench.
  • Action
    On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm. **Action to be Taken by Customer**: During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a magnet quench ensure strict adherence to the Instructions for Use: Release of helium gas in the examination room" If helium gas is not vented properly after the Magnet Emergency Off button is used or during a quench (for example if the helium vent pipe is blocked) a high concentration of helium gas may build up in the examination room. This gas forms clouds of cold mist. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation. If helium enters the examination room: " Immediately remove all persons from the examination room. " Do not switch off air circulation and ventilation in the examination room. " Do not reenter the examination room until it is confirmed that the air oxygen content is at a safe level. "Emergency procedures" The User is required to establish emergency procedures for the following situations: " A medical emergency " A fire " An emergency that requires immediate removal of the magnetic field " The release of helium gas into the examination room Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement. (Instructions for Use R5.3) Philips will schedule an inspection of all MRI systems that may be affected by this notice. If applicable the spare metal burst disk on site will also be replaced during this inspection. Metal Burst disks on all aff

Device

Device Recall Nuclear, Magnetic Resonance Imaging
  • Model / Serial
    (Added 6/25/18): 32550 22129 20226 21715 21558 21805 22134 13005 20027 21789 21264 21236 12078 20129 21639 20021 33037 21230 21231 20249 32171 21493 20149 8770 20154 32816 20173 20260 22096 21999 20050 20213 12074 21968 32508 21482 21688 39035 39005 21935 21572 20071 12100 12124 21891 39068 21609 22315 20106 39060 21998 32080 18673 21045 20331 22207 32500 32219 21099 8715 21351 21334 11024 8442 32085 8971 32084 22319 22286 21666 21693 32481 8165 21066 32003 8996 11027 33625 21930 21321 21798 20185 21776 22012 22167 12017 32344 21036 20321 20000 22089 21237 20282 32034 22245 11028 32131 39024 20257 21192 21957 21634 32616 21464 32346 20156 20065 21752 11052 21284 22001 11019 33675 10077 11094 21878 21328 21320 20236 20252 21070 20281 21479 20096 20126 21879 21976 21380 12061 21599 20204 20028 21681 11069 12021 12012 20161 32644 21304 13081 20141 32388 21268 21773 12056 12181 20248 32390 22212 21860 32689 39021 32739 11081 11059 32792 21721 20120 32083 21851 11007 21574 32002 20072 21638 11048 21687 20291 32329 39055 22140 21788 21108 21962 39025 21251 22066 21883 21806 11058 8371 12065 21965 20210 21076 12182 32233 18528 32474 21494 32824 21882 21176 22008 20062 32314 22130 32174 32033 21973 22210 8361 21113 22288 32966 11080 20023 20036 22155 21111 21168 20045 20047 11015 32185 21664 32424 20119 20280 22159 33157 22215 21925 12015 21993 12132 12112 21183 32463 32717 11074 32198 21110 11037 22222 20049 32772 32712 22004 39027 12106 13012 20088 21508 21868 22110 21103 21340 21381 8578 12031 32095 20118 21106 21967 21754 20005 21712 20314 22084 21603 12123 22252 22268 39061 32226 32507 32343 20212 22092 32581 21313 22160 21504 21713 32351 11020 12051 39016 12034 21377 13020 21589 21435 21953 8020 11090 21424 10058 21096 20272 32255 11026 20277 20297 21290 12064 20128 21958 22136 20058 21725 12066 32381 13066 21104 20307 21071 21405 11016 20265 13048 13049 11010 21286 22025 21178 20179 21240 12037 21630 12144 21667 32125 32517 39017 12024 10703 11023 21455 22343 8782 21272 21475 12075
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide; International - Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Chile, China, Colombia, Congo (Democratic Republic of the), Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Republic of Korea - South Korea, Kuwait, Kyrgyzstan, Latvia, Lebanon, Lesotho, Libya, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Mauritius, Mexico, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of Panama, Papua New Guinea, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, Yemen & Zimbabwe.
  • Product Description
    Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781346 & 8) || Achieva 1.5T Model 781382 || Product Usage: || Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA