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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0443-2022

iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301

Publicado el 5 de enero de 2022 · Inicio del retiro: 21 de octubre de 2021

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

Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation of new accounts with full user rights.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
AMO Manufacturing USA, LLC
Distribuidor
US: CA, TX, FL, LA, MD, IA, MA, VA, SD, MN, MO, NC, TN, SC, WA, NV, OH, KY, IN, CO, NJ, OK, NH, UT, AR, NY, AK, ND, NE, IL, AL, HI, CT, DE, KS, GA, OR, MS, PA, MT, ME, MI, AZ, ID, WI, VT, NM, CA. OUS: Canada, Mexico, Russian Federation, Turkey, Brazil, Egypt, Iraq, Saudi Arabia, Jordan, Norway, Colombia, Germany, Malaysia, India, Oman, Azerbaijan, Canada, Slovakia, Lebanon, Spain, Ireland, Italy, South Korea, Bangladesh, Chile, Taiwan, Tunisia, Kazakhstan, Libya, Argentina, Singapore, Austria, Australia, Vietnam, Greece, Poland, Indonesia, Yemen, Great Britain, South Africa, Croatia, France, Czech Republic, Algeria, Thailand, Bulgaria, United Arab Emirates, Belgium, Japan, China, Nepal, Israel, Switzerland, Dominican Republic, Hong Kong, Portugal, Ecuador, Kuwait, Netherlands, Slovenia, Philippines
Lote
G300 with Windows XP. G301 with Windows 7 Embedded System.
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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