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U.S. Department of Health and Human Services

Class 2 Device Recall Nuclear, Magnetic Resonance Imaging

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  Class 2 Device Recall Nuclear, Magnetic Resonance Imaging see related information
Date Initiated by Firm March 16, 2018
Date Posted April 18, 2018
Recall Status1 Terminated 3 on April 10, 2020
Recall Number Z-1435-2018
Recall Event ID 79451
510(K)Number K052013  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product 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.
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Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Austin O'Connell
800-722-9377
Manufacturer Reason
for Recall		 Potential risk for helium gas inside the MR examination room during a magnet quench
FDA Determined
Cause 2		 Nonconforming Material/Component
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
Quantity in Commerce 8,205 units in total
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.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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