Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to…
Medical device recall Z-2398-2023. Published in FDA’s Enforcement Report on Aug 16, 2023.
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 Aug 16, 2023. 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
- 601 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?
During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
601 Total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Number 781358: UDI-DI: 00884838088115; Serial Numbers: 45481 45476 45473 45470 45469 45467 45464 45463 4546145459 45456 45451 45450 45448 45447 45446 45444 45443 45442 45441 45439 45438 45437 45435 45434 45432 45429 4542845426…
Every code shown here, 1,996 characters
Product Number 781358: UDI-DI: 00884838088115; Serial Numbers: 45481 45476 45473 45470 45469 45467 45464 45463 4546145459 45456 45451 45450 45448 45447 45446 45444 45443 45442 45441 45439 45438 45437 45435 45434 45432 45429 4542845426 45423 45421 45419 45417 45416 45414 45412 45411 45410 45409 45408 45407 45406 45399 45398 45397 45396 4539545394 45393 45392 45391 45390 45382 45381 45379 45378 45377 45376 45374 45372 45371 45370 45369 45368 45367 4536445363 45362 45360 45359 45357 45356 45355 45354 45353 45352 45350 45349 45348 45345 45344 45343 45342 45340 4533945338 45337 45335 45333 45332 45330 45328 45323 45322 45321 45320 45319 45317 45316 45315 45314 45313 45312 4531145310 45309 45308 45307 45306 45305 45304 45303 45302 45300 45296 45295 45294 45293 45292 45290 45289 45284 4528245281 45280 45279 45278 45277 45276 45274 45272 45269 45268 45267 45265 45264 45263 45262 45261 45260 45259 4525745253 45252 45250 45249 45248 45247 45246 45245 45244 45243 45242 45241 45238 45237 45236 45235 45231 45229 4522845227 45224 45222 45220 45219 45218 45217 45216 45215 45212 45211 45210 45207 45205 45204 45203 45197 45195 4519445193 45192 45191 45190 45189 45188 45187 45186 45185 45184 45183 45181 45180 45179 45178 45177 45176 45174 4517145170 45169 45168 45165 45164 45163 45162 45161 45160 45159 45158 45157 45156 45155 45154 45153 45152 45151 4515045149 45148 45147 45146 45145 45144 45142 45141 45140 45139 45138 45137 45136 45134 45133 45132 45131 45129 4512845127 45124 45123 45122 45121 45120 45119 45118 45116 45115 45114 45113 45112 45111 45109 45108 45107 45106 45105 4510245100 45099 45098 45097 45096 45095 45094 45093 45092 45091 45090 45089 45088 45087 45086 45085 45084 45082 4508145080 45079 45078 45077 45076 45075 45072 45071 45070 45068 45067 45066 45065 45064 45062 45061 45060 45058 4505645055 45054 45053 45052 45051 45050 45049 45048 45047 45046 45045 45044 45043 45042 45041 45040 45039 45037 4503645035 45034 45033 45032 45031 45030 45029 45028 45027 45026 45025…
FDA’s list runs to 2,825 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.
US Nationwide. Global Distribution.
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.
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 Jun 12, 2023.
- FDA classified it on Aug 10, 2023.
- FDA’s Enforcement Report published it on Aug 16, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America, 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 2,825 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.