FDA-Device2017-05-24Class I
Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441, 989805616411, 989805636631.
Respironics California Inc
Hazard
Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor Controller to Data Acquisition Board ribbon cable to become partially displaced causing momentary high resistance that prevents or restricts data travelling through the cable during the high resistance event.
Sold states
Worldwide Distribution- US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Iceland, India, Indonesia, Iran (Islamic Republic Of), Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Malta, Mexico, Monaco, Morocco, Namibia, Netherlands, Netherlands Antilles, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province Of China, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.
Affected count
30,516 units
Manufactured in
2271 Cosmos Ct, Carlsbad, CA, United States
Products
Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441, 989805616411, 989805636631.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2061-2017Don't want to check this manually?
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