Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
Reported: April 24, 2024 Initiated: February 15, 2024 #Z-1537-2024
Product Description
Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
Reason for Recall
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Details
- Recalling Firm
- Masimo Corporation
- Units Affected
- 21,723 units
- 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.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,. Recalled by Masimo Corporation. Units affected: 21,723 units.
Why was this product recalled? ▼
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2024. Severity: Moderate. Recall number: Z-1537-2024.
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