FDAFDA · Alimentos y medicamentos·N.º oficial Z-0756-2020
CARESCAPE Respiratory Module E-sCAiO
Publicado el 22 de enero de 2020 · Inicio del retiro: 27 de septiembre de 2019
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
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- US OUS: Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea (Republic of), Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Peru, Poland, Republic of Serbia, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, and Unites Kingdom
- Lote
- Mfg. Lot or Serial # UDI # SGV19240073HA 010084068210418021SGV19240073HA11190611 SGV19280017HA 010084068210418021SGV19280017HA11190708 SGV18150053HA 010084068210418021SGV18150053HA11180411 SGV19240172HA 010084068210418021SGV19240172HA11190612 SGV19240084HA 010084068210418021SGV19240084HA11190611 SGV19240085HA 010084068210418021SGV19240085HA11190611 SGV19240076HA 010084068210418021SGV19240076HA11190611 SGV19240142HA 010084068210418021SGV19240142HA11190612 SGV19280114HA 010084068210418021SGV19280114HA11190709 SGV19280029HA 010084068210418021SGV19280029HA11190708 SGV19240095HA 010084068210418021SGV19240095HA11190611 SGV19270021HA 010084068210418021SGV19270021HA11190702 SGV19240272HA 010084068210418021SGV19240272HA11190613 SGV19270085HA 010084068210418021SGV19270085HA11190704 SGV19260064HA 010084068210418021SGV19260064HA11190628 SGV19240108HA 010084068210418021SGV19240108HA11190611 SGV19240104HA 010084068210418021SGV19240104HA11190611 SGV19240129HA 010084068210418021SGV19240129HA11190612 SGV19240103HA 010084068210418021SGV19240103HA11190611 SGV19240109HA 010084068210418021SGV19240109HA11190611 SGV19250088HA 010084068210418021SGV19250088HA11190617 SGV19250157HA 010084068210418021SGV19250157HA11190620 SGV19250049HA 010084068210418021SGV19250049HA11190617 SGV19240060HA 010084068210418021SGV19240060HA11190611 SGV19240268HA 010084068210418021SGV19240268HA11190613 SGV19250003HA 010084068210418021SGV19250003HA11190617 SGV19250061HA 010084068210418021SGV19250061HA11190617 SGV19250093HA 010084068210418021SGV19250093HA11190617 SGV19250110HA 010084068210418021SGV19250110HA11190620 SGV19250125HA 010084068210418021SGV19250125HA11190620 SGV19260066HA 010084068210418021SGV19260066HA11190628 SGV19260091HA 010084068210418021SGV19260091HA11190628 SGV19250132HA 010084068210418021SGV19250132HA11190620 SGV19260071HA 010084068210418021SGV19260071HA11190628 SGV19250114HA 010084068210418021SGV19250114HA11190620 SGV19290096HA 010084068210418021SGV19290096HA11190716 SGV19250102HA 010084068210418021SGV19250102HA11190620 SGV19280088HA 010084068210418021SGV19280088HA11190708 SGV19270089HA 010084068210418021SGV19270089HA11190704 SGV19240195HA 010084068210418021SGV19240195HA11190612 SGV19260093HA 010084068210418021SGV19260093HA11190628 SGV19300001HA 010084068210418021SGV19300001HA11190723 SGV19280113HA 010084068210418021SGV19280113HA11190709 SGV19240185HA 010084068210418021SGV19240185HA11190612 SGV19270127HA 010084068210418021SGV19270127HA11190705 SGV19250067HA 010084068210418021SGV19250067HA11190617 SGV19270084HA 010084068210418021SGV19270084HA11190704 SGV19280163HA 010084068210418021SGV19280163HA11190709 SGV19280083HA 010084068210418021SGV19280083HA11190708 SGV19270011HA 010084068210418021SGV19270011HA11190702 SGV19260047HA 010084068210418021SGV19260047HA11190628 SGV19280087HA 010084068210418021SGV19280087HA11190708 SGV19240101HA 010084068210418021SGV19240101HA11190611 SGV19240094HA 010084068210418021SGV19240094HA11190611 SGV19240114HA 010084068210418021SGV19240114HA11190611 SGV19240132HA 010084068210418021SGV19240132HA11190612 SGV19240159HA 010084068210418021SGV19240159HA11190612 SGV19240180HA 010084068210418021SGV19240180HA11190612 SGV19240181HA 010084068210418021SGV19240181HA11190612 SGV19240112HA 010084068210418021SGV19240112HA11190611 SGV19240150HA 010084068210418021SGV19240150HA11190612 SGV19240179HA 010084068210418021SGV19240179HA11190612 SGV19240183HA 010084068210418021SGV19240183HA11190612 SGV19240196HA 010084068210418021SGV19240196HA11190612 SGV19240204HA 010084068210418021SGV19240204HA11190612 SGV19240211HA 010084068210418021SGV19240211HA11190612 SGV19270040HA 010084068210418021SGV19270040HA11190702 SGV19280005HA 010084068210418021SGV19280005HA11190708 SGV19280010HA 010084068210418021SGV19280010HA11190708 SGV19240276HA 010084068210418021SGV19240276HA11190613 SGV19270064HA 010084068210418021SGV19270064HA11190704 SGV19270082HA 010084068210418021SGV19270082HA11190704 SGV19270111H
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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