SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for…
Medical device recall Z-1860-2024. 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
- 617 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?
SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782146; 782112; 781260
617 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: N/A Serial Numbers: 8750 8554 9013 18574 18801 18988 20211 33385 8646 8156 8178 8752 10139 10164 11076 21379 8118 21175 72250 33044 33246 11100 18583 18746 18853 18965 18986 20003 20115 21138 21349 21384 21748 22144 22266 18561…
Every code shown here, 1,998 characters
UDI-DI: N/A Serial Numbers: 8750 8554 9013 18574 18801 18988 20211 33385 8646 8156 8178 8752 10139 10164 11076 21379 8118 21175 72250 33044 33246 11100 18583 18746 18853 18965 18986 20003 20115 21138 21349 21384 21748 22144 22266 18561 20116 5572 8240 8734 8808 8985 10183 12030 21466 8713 8917 10087 10130 18673 18701 18803 21775 18872 8090 22220 8087 8215 8601 8923 13026 18690 21003 21458 8427 10528 10900 8862 21333 21710 21768 22255 22256 22257 21050 21554 22070 5425 5447 5463 5484 5536 5539 5550 8001 8010 8025 8084 8096 8129 8175 8179 8263 8318 8321 8387 8397 8401 8407 8456 8476 8559 8611 8642 8704 8736 8804 8885 9020 10008 10033 10061 10075 10117 10170 10174 10179 10191 10717 11000 11001 11030 11031 11102 11108 12082 12121 13082 18013 18565 18631 18644 18697 18894 18906 18938 18957 20057 20070 20160 21015 21018 21020 21082 21142 21171 21453 21814 21932 21979 22194 21033 5523 18665 8512 5499 5505 8657 21296 10029 8054 8350 11064 11072 12053 13011 18575 18718 18720 18940 20032 20055 20206 20295 21004 21087 21091 21141 21184 21210 21223 21247 21261 21347 21451 21555 21576 21582 21611 21680 21691 21694 21737 21739 21755 21863 21912 21942 22017 22018 22086 22093 22103 22224 21801 8213 5466 5537 5546 8045 8311 8330 8365 8395 8424 8431 8478 8641 8667 8712 8786 8840 9004 10044 10102 10220 10457 10552 10554 11017 11046 13001 18069 18101 18509 18511 18548 18655 18788 18970 20111 20132 20164 20165 20196 20413 21011 21032 21362 21551 21565 21623 21671 21746 21809 21890 21892 22044 22055 22296 22299 8591 18597 5511 8012 8057 8060 8094 8305 8309 8481 8517 8531 8711 8724 8831 8843 8857 8887 8896 8913 8949 9007 10007 10151 10498 10513 10906 10913 11005 11042 11091 12114 12120 13029 13046 13047 13062 13073 18017 18038 18060 18107 18524 18670 18704 18929 20002 20011 20035 20187 20195 20209 20237 20263 20278 20288 20302 20319 21062 21089 21129 21156 21182 21209 21213 21222 21278 21326 21355 21403 21448 21482 21519 21560 21579 21640 21697 21759 21780 21792 21969 21987 22013 22031…
FDA’s list runs to 3,574 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 3,574 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.