Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a…
Medical device recall Z-1836-2024. Published in FDA’s Enforcement Report on May 29, 2024.
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 May 29, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1585 units 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?
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s technical room, resulting in Smoke and/or fire
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343
1585 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: (01)00884838004108(21) Serial Number 32307 33454 33668 32302 32401 32679 32699 32814 32894 32913 32923 32974 33002 33071 33073 33224 33227 33386 33387 33485 33488 33493 33502 33503 33518 33551 33571 33683 33704 33713 33746 32306…
Every code shown here, 1,995 characters
UDI-DI: (01)00884838004108(21) Serial Number 32307 33454 33668 32302 32401 32679 32699 32814 32894 32913 32923 32974 33002 33071 33073 33224 33227 33386 33387 33485 33488 33493 33502 33503 33518 33551 33571 33683 33704 33713 33746 32306 32475 33569 32075 32797 32326 33175 33519 33364 33702 32853 32100 32112 32186 32193 32216 32223 32243 32276 32277 32278 32301 32304 32339 32358 32367 32377 32484 32487 32493 32502 32565 32569 32570 32574 32598 32641 32655 32671 32695 32747 32782 32790 32843 32882 32893 32895 32897 32908 32912 32914 32945 32946 32959 32977 32981 32988 32995 33000 33011 33013 33055 33060 33064 33067 33074 33076 33101 33116 33118 33129 33134 33135 33136 33148 33184 33189 33190 33199 33225 33242 33244 33245 33254 33255 33275 33283 33286 33289 33293 33296 33305 33311 33330 33333 33335 33367 33370 33372 33388 33399 33402 33406 33408 33412 33414 33463 33478 33479 33480 33494 33526 33527 33539 33540 33541 33542 33543 33544 33545 33547 33549 33563 33564 33566 33567 33568 33570 33582 33603 33604 33632 33646 33649 33650 33715 33717 33722 33723 33724 33747 33748 33749 33750 33751 33752 33787 33788 32097 33675 32255 32621 32634 32846 32847 33096 33382 33438 33447 32093 32124 32155 32190 32204 32205 32209 32247 32275 32289 32290 32294 32300 32321 32325 32408 32417 32421 32427 32431 32439 32451 32460 32471 32476 32485 32486 32494 32499 32501 32510 32544 32559 32562 32592 32600 32601 32609 32619 32620 32627 32628 32629 32640 32642 32645 32646 32647 32648 32649 32659 32660 32664 32677 32688 32692 32700 32702 32703 32705 32708 32716 32720 32727 32728 32733 32740 32759 32766 32767 32773 32779 32788 32789 32801 32806 32812 32818 32819 32826 32831 32835 32842 32855 32865 32869 32870 32871 32872 32874 32875 32876 32885 32890 32898 32900 32902 32921 32927 32928 32930 32931 32933 32934 32940 32943 32951 32952 32956 32962 32968 32970 32973 32976 32978 32979 32980 32991 32994 32996 32997 33001 33004 33032 33040 33047 33049 33050 33052 33053 33058 33072 33080 33081 33083…
FDA’s list runs to 9,583 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 and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 May 3, 2024.
- FDA classified it on May 17, 2024.
- FDA’s Enforcement Report published it on May 29, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America Llc, of Cambridge, 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 9,583 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.