Ingenia 1.5T
Medical device recall Z-1845-2024. 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
- 2262 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?
Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315
2262 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: (1) 782140 (01)00884838108646(21); (2) 782115 (01)00884838099043(21); (3) 782101 (01)00884838098275(21); (4) 781396 (01)00884838009820(21); (5) 781341 (01)00884838055322(21); (6) 781315 (01)00884838099715(21); Serial Numbers: 61019…
Every code shown here, 1,998 characters
UDI-DI: (1) 782140 (01)00884838108646(21); (2) 782115 (01)00884838099043(21); (3) 782101 (01)00884838098275(21); (4) 781396 (01)00884838009820(21); (5) 781341 (01)00884838055322(21); (6) 781315 (01)00884838099715(21); Serial Numbers: 61019 61140 61080 61067 61091 61114 61028 61039 61040 61041 61000 61002 61003 61006 61009 61013 61017 61032 61058 61065 61066 61074 61075 61076 61097 61106 61124 61060 61001 61004 61008 61011 61023 61025 61026 61034 61035 61042 61046 61054 61055 61062 61063 61115 61078 61015 61119 61005 61020 61043 61085 61087 61088 61029 61030 61033 61036 61037 61045 61051 61052 61057 61061 61064 61068 61069 61070 61072 61095 61123 61116 61117 61125 61126 61129 61130 61027 61108 61109 61131 61144 61107 61138 61142 61143 61102 61103 61007 61014 61018 61016 61038 61073 61079 61024 61031 61059 61082 61084 61092 61093 61096 61101 61022 61044 61047 61049 61050 61053 61056 61094 61105 61112 61132 87260 70040 70229 70607 70763 84030 84108 84126 84234 84257 84596 87005 87146 70064 70113 70603 70604 70605 70704 70725 70767 70768 70794 70812 84539 70232 70279 70367 70374 70375 70461 70742 70764 70471 70780 84566 84621 84629 84667 87214 87215 70488 70832 70071 70311 70916 84098 84343 84765 70088 70110 70111 70161 70177 70204 70244 70269 70446 70448 70459 70470 70612 70662 70663 70664 70665 70666 70667 70668 70678 70691 70755 70845 70864 70866 70867 70868 70942 70943 70969 84178 84179 84180 84302 84303 84330 84381 84384 84385 84387 84451 84844 84976 87028 87040 87061 87098 87124 87125 87126 87135 87177 87180 87206 87207 87221 87222 87271 87290 87297 84300 84249 84891 70221 70286 70641 70655 70712 70730 70851 70858 84644 84649 70424 84092 84311 84730 84744 84766 84890 84982 84986 87151 87171 87191 70974 70981 70987 70997 84010 84066 84082 84110 84150 84153 84197 84204 84230 84242 84256 84262 84287 84290 84291 84307 84310 84318 84320 84321 84327 84328 84383 84389 84397 84399 84411 84414 84417 84422 84427 84452 84496 84497 84503 84515 84525 84531 84532 84542 84582…
FDA’s list runs to 13,801 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 13,801 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.