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
Check against the official notice below — it lists the full affected range.
Getinge is recalling approximately 37,000 ventilators worldwide (11,089 in the US), including Maquet Critical Care AB/Getinge Servo-u, Servo-n, Servo-u MR, and Servo-ai ventilator systems. The devices may generate a combination of alarms that can result in loss of communication and loss of ventilation. If a ventilator stops ventilating, patients may experience hypoventilation and desaturation, potentially leading to hypoxemia, hypoxic injury, and circulatory failure.
The affected ventilators have been distributed across the US and numerous international locations. Specific serial numbers and UDI codes have been identified for the recalled units. However, the source document does not specify what remedy or corrective action consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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, Austra Quantity: 37000 (11089 US) Lot/code info: 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 463
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.