Maquet Critical Care AB/Getinge Servo-u Ventilator System
Medical device recall Z-1560-2022. Published in FDA’s Enforcement Report on Aug 31, 2022.
- FDA Class I
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 31, 2022. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 37000 (11089 US) 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device stops ventilating due to this issue, it may lead to hypoventilation and consequently desaturation, with patient outcomes including hypoxemia and hypoxic injury, which might result in circulatory failure.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
37000 (11089 US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: Servo-air: 73257100031183 Servo-u, Servo-n, Servo-u MR: 7325710001117R Serial Numbers: 46385 46685 46697 46841 3417 46702 46703 46704 46705 46824 46826 46827 46828 46558 46559 46560 46561 46563 46564 46565 46566 46562 46557 46580…
Every code shown here, 1,998 characters
UDI-DI: Servo-air: 73257100031183 Servo-u, Servo-n, Servo-u MR: 7325710001117R Serial Numbers: 46385 46685 46697 46841 3417 46702 46703 46704 46705 46824 46826 46827 46828 46558 46559 46560 46561 46563 46564 46565 46566 46562 46557 46580 46337 46576 46577 46578 46579 46574 46575 46478 46479 46572 46573 46454 46460 46461 46462 46463 46464 46465 46466 46468 46467 46469 46470 46471 46472 46473 46474 46475 46476 46477 3397 3398 3399 245 3418 3420 3421 3422 3423 3424 3425 3426 3427 3428 3429 46567 234 46568 46569 46570 46571 233 235 236 237 46328 240 241 238 239 3370 46353 46345 46346 46347 46349 46350 46351 46352 46341 46342 46344 3365 3366 23857 45262 45268 46321 46706 46683 46684 46686 46687 46691 46693 46694 46692 46695 46696 46698 46699 46700 46701 232 46413 46412 46414 46415 46416 46417 46418 46419 23858 46646 46647 46648 46649 46650 46651 46652 46653 46654 46655 3328 3326 3327 3329 46407 46408 46405 46409 46406 46410 46411 3367 3368 3369 46401 46402 46403 46404 46400 46399 46389 46390 46391 23760 227 228 3364 225 226 46392 23697 23698 23699 46533 46534 46535 46536 46537 46538 46539 46540 46382 46383 46384 46386 46388 46387 222 23749 23750 23751 23752 23753 23754 23755 23756 23757 23758 23759 23761 23762 23763 218 217 219 220 216 46324 46455 46456 46457 46458 46459 46505 46332 46343 46327 46329 46445 46446 46447 46448 46449 46450 46451 46452 46453 46330 46331 46488 46336 46338 46339 46340 46496 46326 46444 46489 46490 46491 46492 46493 46494 46495 46316 46317 46322 46323 46320 46333 46506 46507 46508 46509 46510 46334 46335 46502 46503 46504 46497 46498 46499 46500 46501 46487 46348 46325 46188 3258 3259 3301 46288 46289 46292 46290 46311 46312 46291 46296 46313 46314 46297 46298 46299 46294 46293 46295 46315 46300 46301 46302 46303 46310 46305 46304 46306 46307 46308 46309 46280 46282 46283 46284 46285 46286 46287 46281 23650 23651 23652 23653 23654 23655 23656 23657 23658 23659 23660 23661 46263 46264 46254 46253 46243 46244 46245 46246 46247 46248 46249 46250…
FDA’s list runs to 65,987 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, Poland, Spain, France, Germany, Czech Republic, Italy, Belgium, Estonia, Greece, Finland, Portugal, Netherlands, Romania, Austria, Slovakia, Lithuania, Ireland, Latvia, Norway, Sweden, Malaysia, China, Singapore, Taiwan, Iceland, Slovenia, Hungary, Bulgaria, Denmark, Croatia, United Kingdom, Russia, Hong Kong, United Arab Emirates, Canada, Switzerland, Australia, New Zealand, Serbia, Kenya, South Africa, Palestine, India, Colombia, Macau, Argentina, Mexico, Japan, Brazil, Israel, South Korea, Turkey, Peru, Ukraine, Thailand, Polynesia(French), Morocco, Saudi Arabia, Iran, Martinique (French), Costa Rica, Kuwait, Algeria, Saint Helena, Syria, Chile, Qatar, Fiji, Lebanon, Sri Lanka, Jordan, Oman, Pakistan, Ecuador, Botswana, Mozambique, Netherlands, Antilles, Bolivia, Andorra, Aruba, Faroe Islands, Egypt, Libya, Indonesia, Bahrain, Uruguay, Guadeloupe (French), Puerto Rico, Bosnia-Herzegovina, Paraguay, Nepal, Nicaragua, Vietnam, Tunisia, El Salvador, Tanzania, Papua New Guinea, Philippines, Nigeria, Myanmar, Dominican Republic, Cuba, Russian Federation, Honduras, Zimbabwe, Moldova, Republic of Bangladesh, Maldives, Angola Mauritius, Sudan, Turkmenistan, Panama, Rwanda, Brunei Darussalam, and Georgia.
The states and territories these words name
- Georgia
- Puerto Rico
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 Jul 20, 2022.
- FDA classified it on Aug 22, 2022.
- FDA’s Enforcement Report published it on Aug 31, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Getinge Usa Sales Inc, of Wayne, NJ.
- 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 65,987 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.