Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera…
Medical device recall Z-1433-2018. Published in FDA’s Enforcement Report on Apr 25, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 25, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 8,205 units in total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Potential risk for helium gas inside the MR examination room during a magnet quench
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
8,205 units in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
(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…
Every code shown here, 1,999 characters
(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…
FDA’s list runs to 2,790 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 16, 2018.
- FDA classified it on Apr 18, 2018.
- FDA’s Enforcement Report published it on Apr 25, 2018.
- FDA terminated it on Apr 10, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Electronics North America Corporation, of Andover, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,790 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.