Achieva 3.0T
Medical device recall Z-1839-2024. 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
- 386 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?
Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
386 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: (1) 781345 N/A; (2) 781344 N/A; (3) 781278 (01)00884838004139(21); (4) 781277 N/A; (5) 781177 N/A Serial Numbers: 24079 34231 34256 34289 34220 34308 34139 34200 34213 34255 34258 34276 34301 34306 34020 34052 34082 34113 34120…
Every code shown here, 2,000 characters
UDI-DI: (1) 781345 N/A; (2) 781344 N/A; (3) 781278 (01)00884838004139(21); (4) 781277 N/A; (5) 781177 N/A Serial Numbers: 24079 34231 34256 34289 34220 34308 34139 34200 34213 34255 34258 34276 34301 34306 34020 34052 34082 34113 34120 34123 34230 34234 34235 34239 34240 34247 34260 34264 34270 34272 34274 34285 34287 34288 34297 34298 34299 34309 34312 34056 34282 34023 34144 34228 24115 34001 34095 34138 34143 34165 34269 34293 34300 34305 34115 34225 34253 34038 34047 34077 34126 34135 34160 34206 34254 34268 34275 34118 34237 34271 34273 34291 34242 34261 34290 34033 34104 34281 34086 34106 34125 34159 34241 34263 34286 34294 34295 34311 34022 34043 34208 34109 34130 34203 34207 34304 34074 34028 34029 34030 34034 34065 34066 34071 34073 34085 34201 34011 38295 38074 38191 38247 38254 38276 38326 38346 38355 38363 38285 38043 38073 38087 38092 38098 38108 38124 38140 38152 38157 38158 38171 38181 38185 38189 38190 38194 38196 38206 38209 38210 38212 38215 38216 38227 38231 38233 38236 38238 38240 38245 38248 38249 38252 38255 38257 38258 38260 38264 38266 38267 38269 38270 38271 38279 38282 38284 38287 38292 38293 38298 38299 38303 38304 38307 38314 38318 38319 38320 38321 38324 38327 38328 38329 38330 38332 38335 38338 38339 38340 38343 38344 38347 38349 38351 38358 38360 38361 38367 38368 38370 38372 38401 38402 38405 38407 38408 38410 38412 38414 38415 38420 38421 38423 38424 38425 38426 38427 38429 38430 38431 38432 38433 38436 38437 38438 38439 38441 38442 38443 38445 38447 38448 38450 38453 38454 38456 38457 38458 38128 38288 38082 38174 38253 38044 38049 38079 38139 38141 38151 38167 38170 38188 38220 38228 38127 38145 38009 38034 38162 38251 38336 38354 38359 38055 38056 38278 38207 38021 38031 38054 38059 38061 38086 38095 38104 38115 38133 38137 38169 38186 38187 38193 38223 38237 38262 38273 38280 38313 38272 38322 38323 38337 38345 38200 38268 38090 38172 38265 38046 38150 38197 38217 38225 38261 38067 38130 38022 38047 38093 38241 38060 38138 38017…
FDA’s list runs to 2,432 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 2,432 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.