FDAFDA · Alimentos y medicamentos·N.º oficial Z-1537-2013
Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717 (989805627441) DU1053617 (989805616411) U1053614 (989805636441) U1053617 (989805636631) Power Mgmt. Board, Respironics Material P/N: 1054358, Philips 12 Digit P/N: 4536561512581. The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 lbs.) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
Publicado el 26 de junio de 2013 · Inicio del retiro: 4 de junio de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Respironics California Inc
- Distribuidor
- Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt , Finland, France, Germany, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Kenya, Kuwait, Lebanon, Libya, Malaysia, Malta, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Utd.Arab.Emir. and Vietnam.
- Lote
- V60 Unit Serial Numbers: 201001587 201001594 100066488 100017106 100017114 100017223 100017224 100017230 100017234 100006282 100078254 100078560 100078563 100080057 100013022 100004544 100013661 100013664 100013472 100013658 100042656 100049569 100005498 100014349 100014422 100014430 100014432 100014436 100014438 100014439 100014640 100014643 100014644 100014935 100014936 100014938 100014939 100015003 100082002 100082006 100082083 100082084 100045123 100045295 100030471 100030479 100030484 100030602 100034394 100034398 100034584 100034587 100041191 100014350 100025026 100025032 100025927 100025929 100025930 100025943 100025993 100025994 100025999 201001894 100057883 100057980 100035420 100035575 100035733 201002953 100082192 100082207 100082208 100042116 100021037 100021042 201001495 201001501 100072453 100073915 100037767 100037873 100038506 100038513 100038519 100038807 100038809 100038812 100038925 100038933 100038937 100038944 100038946 100038947 100040748 201003324 100040752 100009963 100009972 100010387 100010388 100044617 100044774 100044791 100066222 100066562 100031574 100081553 100081853 100016549 100016578 100009088 100010389 201000065 201002801 201002865 100003757 100003007 100016742 100016744 100028853 100003052 100005251 201000313 100065694 100065699 100009248 100009250 100009333 100009502 100028463 201000948 201000953 100038426 100038518 100038704 100014642 100035346 100035347 201002945 201002946 201002947 100035614 100035743 100038932 100040301 100038709 100049294 100049389 100049390 100049572 100049574 100049697 100049702 100028947 100012269 100012283 100012287 100012288 100012354 100012355 100012356 100012357 100015514 100015515 100015517 100040179 100040190 100040303 100040304 100040307 100064248 100064236 100012874 201001300 100048641 201000381 100078511 100078518 100078519 100078523 100078524 100078527 100012473 100012705 100012767 201001845 201001846 100065226 100065232 201003213 100049920 100050648 100050653 100082637 100082657 201001104 100007707 100009676 100009813 100009815 100009818 100009909 201002553 100044634 201002560 201002586 201002596 201002601 100017251 100037661 100037663 100048301 100048531 100077111 100077112 100077514 100077704 100077708 100048504 100066095 100066167 100074303 100074310 100081571 100048874 100048876 100048882 100048944 100049586 100047575 100047579 100047724 100048252 100048868 100076835 100076836 100056078 100056079 100056080 100056081 100056085 100035425 100081011 100081188 100081189 100063000 100063002 100017356 100016630 100011732 100011738 100011802 100015004 100024476 100024484 201001843 201001849 100066706 100008437 100003690 100021830 100008146 100057022 100057039 100057040 100057121 100057122 100057128 100059831 100057993 100038424 100038734 100032467 100032470 100042365 100042467 201000806 201000807 201000817 201000829 201000840 201000843 201000844 201000846 201000938 201000982 100012081 100012168 100012255 100012259 100012260 100012261 100017292 100048199 100048200 100048201 100048275 100050894 100051214 100051228 100051746 100051747 100051748 100051751 100051752 100051757 100051854 100051856 100051857 100051858 100051860 100051864 100051866 100051867 100051868 100053144 100053145 100053146 100053147 100053148 100053186 100053230 100053231 201000765 201000776 201000777 201000782 201000783 100020313 100048653 100077082 100077174 100077177 100073168 100073176 100066007 100080999 201002557 201002591 201000096 100082656 100048308 100048530 100048638 100048640 100048642 100048644 100048649 100048654 100013571 100016363 100017255 100017256 100017259 100017294 100048872 100049358 100049707 100077175 100077192 100
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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