Medical Device Recall: Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
Masimo Corporation · February 15, 2024
Reason for Recall
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Distribution
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Belize, Bolivia, Burkina Faso, Burundi, Cambodia, Canada, Chile, Colombia, Congo, The Democratic Republic of, Costa Rica, Cyprus, Czech Republic, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Israel, Italy, Japan, Lesotho, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Poland, Puerto Rico, Qatar, Rwanda, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tanzania, United Republic Of, Thailand, Trinidad And Tobago, Uganda, United Kingdom, Uruguay, Yemen, Zimbabwe.
States Affected
NATIONWIDE
Quantity Affected
443 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1536-2024
Status: ongoing
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