FDAFDA · Alimentos y medicamentos·N.º oficial Z-2717-2016
NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Packaged X-Ray System Black, Part Number 08500024; NOMAD Pro2 Packaged X-Ray System, GBL, Part Number 08500025 and Part Number 08500026; NOMAD Pro2 Packaged X-Ray System, GLB, Vet, Part Number 08500027 and Part Number 08500028; NOMAD Pro2 Package X-Ray System, GLB, Black, Part Number 08500029
Publicado el 14 de septiembre de 2016 · Inicio del retiro: 18 de julio de 2016
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
Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack PCB.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Aribex Inc
- Distribuidor
- AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA. HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY , Puerto Rico, Afghanistan, Argentina, Australia, Bahamas, Bahrain, Belgium, Bermuda, Chile, China, Columbia, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kuwait, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Saudi Arabia, Papua New Guinea, Philippines, Poland, Qatar, Saudi Arabia, Slovenia, South Africa, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, UAE, United Kingdom, Venezuela, Vietnam
- Lote
- Part Number 08500021 - Serial Number Range XD-100921-05 - XD-150109-11, 10000 - 20811, XD-140929-39 - XD-150123-20; Part Number 08500022 - Serial Number Range XE-130528-03 - XE-150123-38, 10000 - 20541, XE-140908-32 - XE-150123-40; Part Number 08500023 - Serial Number Range XF-121008-05 - XF-150205-03, 10003 - 20032, XE-150205-01; Part Number 08500024 - Serial Number Range XG-130520-01 - XG-141210-05, 1000 - 20019; Part Number 08500025 - Serial Number Range XI-140303-02 - XI-150210-9, XI-150202-04 - XI-150210-19; Part Number 08500026 - Serial Number Range 10039 - 20041; Part Number 08500027 - Serial Number Range 1000 - 20006, Part Number 08500028 - Serial Number Range 10000 - 20030; Part Number 08500029 - Serial Number Range 10000.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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