Masimo Corporation recalls Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,

Recall date

February 15, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1536-2024

FDA classification

Class II

Brand / firm

Masimo Corporation

Sold / distributed

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, Au…

Why it was recalled

Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,