Home / Recalls / Masimo Corporation / Z-1539-2024

Z-1539-2024 Class II Ongoing

Recalled by Masimo Corporation — Irvine, CA

Recall Details

Product Type
Devices
Report Date
April 24, 2024
Initiation Date
February 15, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
65

Product Description

Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,

Reason for Recall

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

Distribution Pattern

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.

Code Information

UDI:(01)00843997013789/ Serial Numbers: 6000083849 6000083870 6000083875 6000083898 6000083909 6000083932 6000083941 6000083959 6000083974 6000083978 6000083983 6000083991 6000083997 6000083999 6000084011 6000084018 6000084020 6000084042 6000084055 6000084075 6000084084 6000084090 6000084101 6000084106 6000084112 6000084132 6000084133 6000084157 6000084163 6000084181 6000084205 6000084211 6000084222 6000084236 6000084276 6000084290 6000084364 6000084392 6000084394 6000084429 6000084439 6000084442 6000084454 6000084455 6000084457 6000084513 6000084536 6000084543 6000084567 6000084574 6000084575 6000084607 6000084613 6000084647 6000090319 6000090325 6000090331 6000090333 6000090339 6000084465 6000083931 6000083954 6000083963 6000084250 6000084309

Other recalls by Masimo Corporation

  • Z-1536-2024 Class II — Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, (February 15, 2024)
  • Z-1538-2024 Class II — Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, (February 15, 2024)
  • Z-1537-2024 Class II — Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, (February 15, 2024)
  • Z-1983-2023 Class II — Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 (April 21, 2023)
  • Z-1984-2023 Class II — Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 (April 21, 2023)
  • Z-1986-2023 Class II — Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 (April 21, 2023)
  • Z-1985-2023 Class II — Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 (April 21, 2023)
  • Z-0338-2016 Class II — rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAI (October 28, 2015)
  • Z-0213-2015 Class II — Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line (September 30, 2014)
  • Z-1187-2013 Class II — Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories ar (March 13, 2013)