FDAFDA · Food and drugs·Recall number Z-0008-2015
Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Published October 29, 2014 · Recall initiated: September 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not operate. This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Respironics California Inc
- Distributor
- Worldwide Distribution - USA, Argentina, China, Egypt, Ethiopia, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Jordan, Libyan Arab Yamahiriya, Malaysia, Mali, Mexico, Myanmar (Burma). Nepal, Nigeria. Pakistan, Peru, Philippines, Serbia, Singapore, South Africa, Sri Lanka, United Republic of Tanzania, Thailand, Vietnam, Zimbabwe, Republic of Korea, and Netherlands.
- Lot
- Serial Numbers: VS0002577 VS0002579 VS0002580 VS0002581 VS0002583 VS0002584 VS0002585 VS0002586 VS0002587 VS0002588 VS0002589 VS0002590 VS0002593 VS0002595 VS0002596 VS0002599 VS0002602 VS0002603 VS0002604 VS0002605 VS0002606 VS0002609 VS0002610 VS0002611 VS0002613 VS0002615 VS0002616 VS0002625 VS0002630 VS0002746 VS0002750 VS0002752 VS0002753 VS0002759 VS0002728 VS0002773 VS0002765 VS0002772 VS0002828 VS0002842 VS0002830 VS0002834 VS0002859 VS0002873 VS0002874 VS0002877 VS0002879 VS0002884 VS0002844 VS0002846 VS0002847 VS0002851 VS0002856 VS0002891 VS0002815 VS0002816 VS0002924 VS0002927 VS0002929 VS0002932 VS0002933 VS0002934 VS0002936 VS0002938 VS0002939 VS0002943 VS0002942 VS0002947 VS0002946 VS0002960 VS0002994 VS0002998 VS0002708 VS0002817 VS0002940 VS0002958 VS0002959 VS0002963 VS0003023 VS0003029 VS0003074 VS0003079 VS0003080 VS0003092 VS0003093 VS0003141 VS0003095 VS0003114 VS0003176 VS0003260 VS0003139 VS0003172 VS0003259 VS0003286 VS0003303 VS0003343 VS0003357 VS0003361 VS0003430 VS0003440 VS0003444 VS0003446 VS0003448 VS0003451 VS0003494 VS0003500 VS0003503 VS0003504 VS0003505 VS0003506 VS0003507 VS0003509 VS0003511 VS0003513 VS0003514 VS0003518 VS0003545 VS0003546 VS0003554 VS0003549 VS0003557 VS0003607 VS0003601 VS0003704 VS0003684 VS0003690 VS0003694 VS0003698 VS0003701 VS0003702 VS0003705 VS0003707 VS0003709 VS0003713 VS0003657 VS0003733 VS0003600 VS0003757 VS0003743 VS0003744 VS0003750 VS0003751 VS0003755 VS0003756 VS0003818 VS0003819 VS0003820 VS0003822 VS0003823 VS0003825 VS0003826 VS0003828 VS0003829 VS0003830 VS0003831 VS0003876 VS0003886 VS0003890 VS0003891 VS0003892 VS0003922 VS0003907 VS0003921 VS0003923 VS0003924 VS0003925 VS0003896 VS0003913 VS0003939 VS0003940 VS0003942 VS0003897 VS0003906 VS0003944 VS0003945 VS0003960 VS0003971 VS0003975 VS0003973 VS0004010 VS0004016 VS0004017 VS0003791 VS0003792 VS0003993 VS0004004 VS0004023 VS0004024 VS0004056 VS0004062 VS0004068 VS0004069 VS0004072 VS0004077 VS0004079 VS0004087 VS0004095 VS0004060 VS0004065 VS0004083 VS0004097 VS0004098 VS0004099 VS0004101 VS0004104 VS0004105 VS0004121 VS0002980 VS0002983 VS3000564 VS3002057 VS3002123 VS3004918 VS3005977 VS3006242 VS3006568 VS3006632 VS3007083 VS3007093 VS3007326 VS3007399 VS3008641 VS3008943 VS3008981 VS3009885 VS3010067 VS3010449 VS3010988 VS3012196 123600002 123600005 123600011 123600018 123600023 123600025 123600029 123600030 123600036 123600039 123600044 123600053 123600056 123600059 123600063 123600077 123600078 123600080 123600081 123600082 123600095 124600102 124600115 124600118 124600157 124600158 124600172 124600179 124600180 124600182 124600183 124600186 124600200 124600201 124600217 124600224 124600225 124600228 124600242 124600247 124600248 124600256 124600257 124600261 124600264 124600266 124600269 124600270 124600278 124600293 124600295 124600296 124600298 124600299 124600301 124600303 124600304 124600306 124600309 124600310 124600312 124600315 124600317 124600321 124600326 124600327 124600329 124600334 124600339 124600343 124600346 124600348 124600354 124600355 124600356 124600358 124600360 124600364 124600373 124600375 124600379 124600381 124600382 124600384 124600386 124600389 124600401 124600410 124600413 124600414 124600430 124600431 124600434 124600440 124600443 124600444 124600446 124600453 124600455 124600457 124600459 124600460 124600463 124600465 124600471 124600476 124600477 124600481 124600483 124600488 124600490 124600491 124600494 124600501 124600502 124600508 124600510 124600512 124600519 124600523 124600525 124600526 124600528 124600529 124600530 124600534 124600535 124600538 124600545 124600546 124600550 124600553 124600555
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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