FDA-Device2024-07-03Class II
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Draeger Medical Systems, Inc.
Hazard
Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and cardiac arrhythmia.
Sold states
US Nationwide distribution. International distribution to Afghanistan, Argentina, Armenia, Australia, Austria, Belarus, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Liechtenstein, Lithuania, Malaysia, Malta, Martinique, Mexico, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Vietnam.
Affected count
34,102 units
Manufactured in
6 Tech Dr, Andover, MA, United States
Products
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2189-2024Don't want to check this manually?
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