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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0910-2021

Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Publicado el 3 de febrero de 2021 · Inicio del retiro: 2 de noviembre de 2020

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Respironics California, LLC
Distribuidor
Worldwide distribution - US Nationwide including Guam and Puerto Rico; Afghanistan, Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, ST. Pier Miquel, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Wallis Futuna, and Zambia.
Lote
Model: V60 Part Number: R1076709 V60 Ventilator, JAPAN OPT: CFLEX,AVAPS,AT+ Serial Numbers: 100065352 100065365 100065371 100065487 100065493 100067423 100067425 100067428 100067431 100067451 100068214 100069518 100070301 100070306 100070398 100070476 100070491 100070492 100070768 100070774 100070776 100070777 100070778 100070780 100070781 100070859 100070862 100070865 100070921 100070922 100070924 100070928 100070929 100070930 100070935 100070966 100070969 100070973 100070976 100070981 100071071 100071073 100071077 100071123 100071461 100071510 100071511 100072415 100072417 100072418 100072499 100072570 100072606 100072607 100072673 100072676 100072679 100072684 100072685 100072688 100072690 100072695 100074195 100075099 100075100 100075104 100075189 100075293 100075312 100075381 100078120 100078132 100078140 100078145 100078266 100078302 100078313 100078362 100078365 100078366 100078372 100079387 100080231 100080233 100080236 100080237 100080239 100080271 100080275 100080276 100080277 100080282 100080285 100080290 100080291 100080292 100080294 100080295 100080297 100080298 100080421 100080422 100080423 100080424 100080425 100080427 100080428 100080429 100080430 100080528 100080529 100080530 100080532 100080533 100080535 100080536 100080537 100080540 100080541 100080542 100080543 100080544 100080545 100080547 100080552 100080553 100080563 100080642 100080643 100080644 100080647 100080650 100080651 100080652 100080653 100080654 100080657 100080658 100080659 100080704 100080706 100080708 100080711 100080713 100080716 100080717 100080721 100080722 100080723 100080724 100080725 100080726 100080729 100080731 100080733 100080734 100080736 100080740 100080840 100080841 100080843 100080845 100080846 100080847 100080849 100080850 100080852 100081698 100083532 100083534 100083537 100083538 100083539 100083561 100083563 100083564 100083567 100083569 100083577 100083601 100083603 100083811 100083813 100083816 100083817 100083821 100083822 100083823 100083824 100083825 100083828 100083830 100083832 100083833 100083920 100083921 100083922 100083923 100083924 100083925 100083926 100083927 100083929 100083930 100084955 100084957 100085084 100085086 100085087 100085089 100085090 100085092 100085095 100085242 100085245 100085248 100085249 100085250 100085253 100085322 100085323 100085324 100085325 100085326 100085328 100085329 100085331 100085332 100085334 100085336 100085337 100085338 100085339 100085380 100085381 100085383 100085385 100085386 100085387 100085388 100085395 100085397 100085480 100085482 100085484 100085485 100085486 100085487 100085488 100086236 100086783 100086891 100086896 100086902 100087025 100087028 100087049 100087050 100087052 100087093 100087095 100087097 100087103 100087104 100087172 100087344 100087350 100087351 100087352 100087353 100087354 100087357 100087358 100087462 100087463 100087464 100087465 100087468 100087471 100087472 100087474 100087475 100087477 100087478 100087482 100087484 100087488 100087489 100087602 100087607 100087608 100087609 100087612 100087613 100087616 100087617 100087682 100087683 100087684 100087685 100087691 100087693 100087695 100087696 100087697 100087698 100087699 100088046 100088054 100088055 100088059 100088060 100088429 100088432 100088433 100088434 100088435 100088437 100088438 100088439 100088859 100089023 100089024 100089025 100089026 100089027 100089028 100089029 100089030 100089031 100089032 100089120 100089121 100089123 100089124 100089125 100089126 100089128 100089129 100089130 100089132 100089133 100089134 100089135 100089136 100089138 100089140 100089141 100089142 100089143 100089144 100089145 100089146 100089147 10008914
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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