SIGNA MR355, SIGNA MR360, NMRI system
Medical device recall Z-1242-2025. 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
- 241 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 MR355, SIGNA MR360, NMRI system
241, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1. SIGNA MR355 A. UDI-DI 00840682144407 System IDs 082427010189 082427010193 082427010195 082427010200 082427010202 082427010205 082427010207 082427010208 082427010209 082427010210 082427020099 082427020120 082427020123 082427020127…
Every code shown here, 1,988 characters
1. SIGNA MR355 A. UDI-DI 00840682144407 System IDs 082427010189 082427010193 082427010195 082427010200 082427010202 082427010205 082427010207 082427010208 082427010209 082427010210 082427020099 082427020120 082427020123 082427020127 082427030181 082427030194 082427030199 082427030205 082427030210 082427030213 082427030217 082427030221 082427030228 082427040273 082427040294 082427040303 082427040307 082427040316 082427040318 082427040323 082427060097 082427070236 082427070240 082427070244 082427070247 082427070255 082427070257 082427070279 082427070285 082427070299 082427070309 082427070312 082427070313 082427070316 082427070327 082427070330 082427070335 082427070339 082427070343 082427070344 082427070348 082427080113 082427080116 082427080118 082427080133 082427080135 082427080137 082427090359 082427090474 082427100436 082427100460 082427100461 082427100466 082427100481 082427100500 082427100506 082427110098 082427110106 082427110125 082427110126 082427110147 082427110153 082427120294 082427120297 082427120306 082427120315 082427120332 082427120336 082427120339 082427120348 082427120362 082427120367 082427120374 082427130130 082427140315 082427140332 082427160293 082427160303 082427160311 082427160312 082427160316 082427160327 082427160333 082427160341 082427160351 082427160352 082427160359 082427160364 082427160366 082427160367 082427160369 082427160374 082427160394 082427160397 082427160406 082427160416 082427160419 082427160421 082427170028 082427170032 082427180074 082427190152 082427190159 082427190179 082427190197 082427190198 082427200165 082427200174 082427200187 082427200192 082427200194 082427200198 082427200212 082427200231 082427210234 082427210239 082427210253 082427210259 082427220100 082427220138 082427230173 082427230175 082427230182 082427230187 082427230205 082427230237 082427230238 082427230242 082427240099 082427240100 082427240101 082427240102 082427240103 082427240104 082427240111 082427240113 082427250095 082427250101 082427250116…
FDA’s list runs to 3,443 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 3,443 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.