Summary
The FDA issued a Class II for Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, by Masimo Corporation. Reason: Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring..
Details
Source
Device Recall
External ID
Z-1539-2024
Action Date
2024-04-24
Status
Ongoing
Category
device
Product Description
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
Lot/Code Info: 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
Quantity Affected: 65
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-15
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 179 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Masimo Corporation has 25 FDA actions in our database, including 8 recalls and 17 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Masimo Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Masimo Corporation have FDA actions?
Masimo Corporation has 25 FDA actions in our database, including 8 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1539-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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