FDA-Device2021-08-04Class II
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
GE Healthcare, LLC
Hazard
Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
Sold states
worldwide distribution US nationwide, Albania, Algeria, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Fiji, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iran, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, State of Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
Affected count
111,728 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2139-2021Don't want to check this manually?
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