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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79451

13 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 16, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Electronics North America Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

13 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 13

Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Multiva 1.5T Model 781076, & 5) Multiva 1.5T 16ch R5 based Model 781078 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.

Z-1430-2018
Recall number
Z-1430-2018
Initiated
March 16, 2018
Classification
Class II
Status
Terminated
Quantity
8,205 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential risk for helium gas inside the MR examination room during a magnet quench

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential risk for helium gas inside the MR examination room during a magnet quench

Code information

None

Distribution pattern

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.

device · product 2 of 13

Intera 0.5T Standard, Model 781101 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.

Z-1431-2018
Recall number
Z-1431-2018
Initiated
March 16, 2018
Classification
Class II
Status
Terminated
Quantity
8,205 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential risk for helium gas inside the MR examination room during a magnet quench

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential risk for helium gas inside the MR examination room during a magnet quench

Code information

(Added 6/25/18): 6051 6003 6046 6004

Distribution pattern

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.

device · product 3 of 13

Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 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.

Z-1432-2018
Recall number
Z-1432-2018
Initiated
March 16, 2018
Classification
Class II
Status
Terminated
Quantity
8,205 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential risk for helium gas inside the MR examination room during a magnet quench

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential risk for helium gas inside the MR examination room during a magnet quench

Code information

(Added 6/25/18): 7149 7210 7082 7212 7015 7174 7081 10327 7073 10332 7063 7040 7119 7095 7272 10104 7005 7213 7057 10326 7128 10339 7230 10329 7183 7098 10053 7080 7011 7178 7139 7126 10192 7217 7066 7171 7136 7038 7050

Distribution pattern

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.

device · product 4 of 13

Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174, 11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195, 14) Intera 1.5T Pulsar New Model 781295, (Added 6/25/18) 15) Intera 1.5T Enterprise

Z-1433-2018
Recall number
Z-1433-2018
Initiated
March 16, 2018
Classification
Class II
Status
Terminated
Quantity
8,205 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential risk for helium gas inside the MR examination room during a magnet quench

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential risk for helium gas inside the MR examination room during a magnet quench

Code information

(Added 6/25/18): 8920 8590 8368 8210 10049 8277 10039 10087 8302 18629 8050 18749 10777 8699 18554 8250 8073 8540 18050 10691 18784 8056 10198 8244 8583 8889 18079 8408 10031 8052 8899 8234 10137 18974 10014 8612 8916 10133 8928 10789 18966 10118 10195 8009 8846 8668 8797 10092 10732 8233 18034 8003 18723 8418 8934 10111 8536 8268 8462 10727 30047 8893 10721 10221 8670 8216 18667 30098 8721 8569 8666 10010 18860 8691 8888 8898 8975 8080 10729 8198 8963 18030 8872 18578 8037 8788 18549 10167 8043 10097 8951 8544 8432 8626 8655 18579 8316 8744 10005 8482 8827 8856 8403 10695 8320 18725 10707 10144 8836 8995 18110 18025 18031 9011 10105 10722 10724 8184 8176 10786 10100 8366 8112 8301 10697 8772 10217 18100 8255 8141 8414 8436 18728 8585 8101 8332 10677 8841 10726 10693 8019 8850 8269 18642 18065 18750 10803 8631 8937 9034 18093 18662 8818 8859 8603 18539 8128 18677 18661 8252 8412 8206 8356 8131 8295 8018 8618 18868 8789 8274 8785 10687 10708 8778 8805 8710 10675 18782 8338 10074 8400 8104 10078 8754 8279 8214 8991 8225 10711 10775 8768 30017 8181 18864 8567 9010 8152 8925 8998 10218 18569 10700 8926 8580 10794 8665 8781 8615 10154 10704 8563 8954 8067 8557 30032 18822 18702 8227 10121 8564 10689 30056 8384 10494 18563 18523 18568 8931 10228 10797 18070 10024 8064 8693 8950 18585 8674 10540 8495 8145 8159 8997 10212 10069 8837 18653 8376 10107 8560 10788 8342 8537 8063 18593 18534 8373 10090 8160 8952 8910 8908 8048 8987 18522 8102 8410 18922 18516 8676 10709 10792 8370 10232 8219 8174 8494 8835 10081 8296 8218 8093 18600 10214 8672 8047 8375 8617 8737 8891 18756 10702 10681 8224 18097 8030 10690 10785 8113 8146 10204 8256 8543 8562 10692 10710 10041 8599 18972 30030 18616 18036 8382 8026 8430 8509 8144 8304 10460 18656 8945 8717 18029 8527 18606 8596 8698 10581 18011 10122 8918 8849 8915 8130 18074 10034 10159 10627 18562 8638 8685 18901 8335 8217 8314 18615 8630 8613 8237 10052 8815 10725 10131 10009 8483 18726 8833 8542 18628 8016 8238 18865 8738 10795 8643 10799 10462 10013 18729 8027 10089 18546 10696 8151 18049 8635 8505 10787 10119 8082 18973 10209 10124 8906 8246 8133 8549 10098 10227 8565 18581 8013 8257 8423 8762 18108 18021 18032 8360 8469 18012 8548 9008 8530 8049 8733 10196 8459 18553 8085 10213 8125 8633 8534 10068 8394 8838 8352 10056 8972 18660 8413 8278 8333 8806 8760 10219 8235 8254 8140 10035 10684 8034 18559 10112 10088 8708 8764 8503 8199 8357 8005 8930 8281 10003 18092 8577 8500 8372 10790 10676 18939 18900 8341 10685 10723 8340 8042 8956 18786 8383 8406 8647 8024 8735 10206 8008 8649 8688 8079 10682 18876 8473 10678 8650 8909 18650 18519 18640 8154 8621 10093 18659 8380 10783 8933 8883 8866 8023 18918 18536 8359 8522 18582 10798 8098 10057 8636 18558 18607 8100 18668 8041 10036 8970 8515 9001 8988 18902 8038 10482 18863

Distribution pattern

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.

device · product 5 of 13

Panorama 1.0T, Model 781250 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.

Z-1434-2018
Recall number
Z-1434-2018
Initiated
March 16, 2018
Classification
Class II
Status
Terminated
Quantity
8,205 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential risk for helium gas inside the MR examination room during a magnet quench

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential risk for helium gas inside the MR examination room during a magnet quench

Code information

(Added 6/25/18): 19063 19061 19010 19003 19050 19021 19039 19038 19041 19051 19001 19077 19046 19011 19056 19034 19016 19024

Distribution pattern

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.

device · product 6 of 13

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.

Z-1435-2018
Recall number
Z-1435-2018
Initiated
March 16, 2018
Classification
Class II
Status
Terminated
Quantity
8,205 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential risk for helium gas inside the MR examination room during a magnet quench

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential risk for helium gas inside the MR examination room during a magnet quench

Code information

(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

Distribution pattern

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.

device · product 7 of 13

Conversion SmarthPath to dStream for 1.5T, Model 781260 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.

Z-1436-2018
Recall number
Z-1436-2018
Initiated
March 16, 2018
Classification
Class II
Status
Terminated
Quantity
8,205 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential risk for helium gas inside the MR examination room during a magnet quench

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential risk for helium gas inside the MR examination room during a magnet quench

Code information

(Added 6/25/18): 39005 20071 18673 8715 8971 8165 8996 39024 10077 18528 32174 8578 10058 21290 10703

Distribution pattern

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.

device · product 8 of 13

Ingenia 1.5T CX, Models 781261 & 781262 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.

Z-1437-2018
Recall number
Z-1437-2018
Initiated
March 16, 2018
Classification
Class II
Status
Terminated
Quantity
8,205 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential risk for helium gas inside the MR examination room during a magnet quench

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential risk for helium gas inside the MR examination room during a magnet quench

Code information

(Added 6/25/18): 41158 70743 70200

Distribution pattern

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.

device · product 9 of 13

T5-NT, Model 78104 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.

Z-1438-2018
Recall number
Z-1438-2018
Initiated
March 16, 2018
Classification
Class II
Status
Terminated
Quantity
8,205 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential risk for helium gas inside the MR examination room during a magnet quench

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential risk for helium gas inside the MR examination room during a magnet quench

Code information

(Added 6/25/18): 561 548 719 734 698 681 541 830 563 717 852 633 574 929 741 942 572 697 649 544 757 647 725 888 516 818 682 537 747 718 751 726 769 502 625 514 761 778 577 554 848 560 624 527 525 523 773 670 532 620 593 558 793 616 505 758 636 672 823 947 590 540 724 653 801 568 646 855 576 545 580 581 506 693 559 551 925 612 623 530 777 917 907 831 652 613 632 675 849 604 944 820 920 650 539 654 941 928 713 657

Distribution pattern

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.

device · product 10 of 13

ACS-NT, Model 78108 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.

Z-1439-2018
Recall number
Z-1439-2018
Initiated
March 16, 2018
Classification
Class II
Status
Terminated
Quantity
8,205 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential risk for helium gas inside the MR examination room during a magnet quench

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential risk for helium gas inside the MR examination room during a magnet quench

Code information

(Added 6/25/18): 5097 5426 5519 5507 5255 5059 5379 5257 5316 5144 5002 5300 5440 5482 5014 5492 5019 5423 5256 5293 5382 5319 5420 5030 5477 5488 5193 5085 5347 5287 5195 5481 5370 5474 5360 5352 5106 5135 5495 5313 5413 5245 5142 5378 5411 5214 5151 5053 5222 5201 5381 5246 5306 5429 5441 5324 5273 5048 5124 5211 5453 5277 5533 5239 5248 5349 5414 5311 5513 5204 5215 5434 5577 5296 5259 5271 5512 5373 5542 5290 5091 5446 5266 5406 5551 5090 5455 5123 5261 5323 5390 5254 5353 5502 5241 5514 5238 5035 5105 5333 5454 5226 5334 5328 5417 5298 5451 5288 5200 5077 5250 5342 5309 5172 5432 5081 5199 5458 5573 5568 5268 5110 5472 5052 5009 5461 5022 5297 5263 5158 5078 5230 5558 5428 5303 5376 5515 5520 5269 5394 5253 5282 5042 5155 5084 5047 5530 5501 5383 5497 5016 5329 5162 5143 5491 5470 5566 5071 5079 5258 5125 5283 5129 5475 5574 5149 5018 5421 5473 5227 5330 5264 5132 5141 5327 5265 5351 5121 5216 5236 5180 5487 5478 5116 5160 5345 5301 5522 5083 5391 5021 5552 5314 5363 5024

Distribution pattern

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.

device · product 11 of 13

T10-NT, Model 78107 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.

Z-1440-2018
Recall number
Z-1440-2018
Initiated
March 16, 2018
Classification
Class II
Status
Terminated
Quantity
8,205 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential risk for helium gas inside the MR examination room during a magnet quench

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential risk for helium gas inside the MR examination room during a magnet quench

Code information

(Added 6/25/18): 4170 4113 4082 4176 4147 4319 4397 4285 4308 4408 4241 4064 4328 4312 4294 4296 4009 4274 4258 4297 4246 4200 4041 4207 4327 4318 4089 4102 4222 4025 4321 4177 4015 4088 4106 4260 4183 4272 4416 4365 4047 4411 4254 4301 4261 4307 4267 4386 4033 4099 4251 4339 4374 4162 4322 4320 4069 4006 4273 4418 4131 4194 4201 4152 4146 4095 4391

Distribution pattern

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.

device · product 12 of 13

Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4) Magnet HFO, Model 781495, 5) Magnet Multiva 16, Model 781496, 6) Magnet Multiva 8, Model 781497 & 7) Magnets Ingenia 1.5T CX, Model 781498 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.

Z-1441-2018
Recall number
Z-1441-2018
Initiated
March 16, 2018
Classification
Class II
Status
Terminated
Quantity
8,205 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential risk for helium gas inside the MR examination room during a magnet quench

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential risk for helium gas inside the MR examination room during a magnet quench

Code information

None

Distribution pattern

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.

device · product 13 of 13

T5 Model 78104 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.

Z-1442-2018
Recall number
Z-1442-2018
Initiated
March 16, 2018
Classification
Class II
Status
Terminated
Quantity
8,205 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential risk for helium gas inside the MR examination room during a magnet quench

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential risk for helium gas inside the MR examination room during a magnet quench

Code information

(Added 6/25/18): 561 548 719 734 698 681 541 830 563 717 852 633 574 929 741 942 572 697 649 544 757 647 725 888 516 818 682 537 747 718 751 726 769 502 625 514 761 778 577 554 848 560 624 527 525 523 773 670 532 620 593 558 793 616 505 758 636 672 823 947 590 540 724 653 801 568 646 855 576 545 580 581 506 693 559 551 925 612 623 530 777 917 907 831 652 613 632 675 849 604 944 820 920 650 539 654 941 928 713 657

Distribution pattern

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.