SIGNA MR380, NMRI system, Non-US Only
Medical device recall Z-1243-2025. Published in FDA’s Enforcement Report on Mar 5, 2025.
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 Mar 5, 2025. 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
- 188 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?
For certain MR systems, a scan can be resumed following a Power Monitor trip when the “6-minute average SAR” is above the limit indicated on the “SAR Display”. The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SIGNA MR380, NMRI system, Non-US Only
188, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
SIGNA MR380 UDI-DI 00195278361257 System IDs 082427020110 082427020116 082427040288 082427040293 082427040296 082427040309 082427070258 082427070264 082427070267 082427070268 082427070272 082427070275 082427070284 082427070286 082427070287…
Every code shown here, 1,995 characters
SIGNA MR380 UDI-DI 00195278361257 System IDs 082427020110 082427020116 082427040288 082427040293 082427040296 082427040309 082427070258 082427070264 082427070267 082427070268 082427070272 082427070275 082427070284 082427070286 082427070287 082427070288 082427070289 082427070292 082427070293 082427070294 082427070295 082427070303 082427070304 082427070305 082427070306 082427070307 082427070310 082427070311 082427070317 082427070320 082427070337 082427090417 082427090428 082427090431 082427090439 082427090462 082427090468 082427100424 082427100427 082427100428 082427100438 082427100443 082427100452 082427100453 082427100465 082427100467 082427100468 082427100470 082427100472 082427100488 082427100498 082427110124 082427110127 082427110131 082427110134 082427110136 082427110137 082427110139 082427110158 082427120299 082427120310 082427120312 082427120317 082427120318 082427120329 082427120347 082427130133 082427130135 082427130136 082427130137 082427130138 082427130142 082427130149 082427130154 082427130160 082427130161 082427130162 082427130163 082427130165 082427130166 082427130167 082427130168 082427130169 082427130171 082427130172 082427130178 082427130179 082427140219 082427140220 082427140221 082427140228 082427140230 082427140233 082427140236 082427140238 082427140239 082427140243 082427140244 082427140247 082427140253 082427140254 082427140255 082427140256 082427140260 082427140261 082427140262 082427140263 082427140264 082427140266 082427140269 082427140270 082427140271 082427140272 082427140276 082427140277 082427140280 082427140281 082427140282 082427140284 082427140286 082427140290 082427140291 082427140292 082427140293 082427140298 082427140302 082427140304 082427140306 082427140312 082427140316 082427150122 082427150123 082427150125 082427150126 082427150133 082427160334 082427160342 082427160371 082427180066 082427180072 082427180073 082427180075 082427180079 082427190189 082427210231 082427210235 082427210243 082427210252 082427220099 082427220101…
FDA’s list runs to 2,569 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.
Domestic US distribution nationwide. International distribution worldwide.
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 Jan 31, 2025.
- FDA classified it on Feb 27, 2025.
- FDA’s Enforcement Report published it on Mar 5, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare (China) Co., Ltd., of Beijing, China.
- 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 2,569 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
-
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.