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Class 2 Device Recall Masimo RadG, Pulse Oximeter (W/Patient Cable |
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| Date Initiated by Firm |
February 15, 2024 |
| Date Posted |
April 12, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1539-2024 |
| Recall Event ID |
94170 |
| 510(K)Number |
K213676
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| Product Classification |
Oximeter - Product Code DQA
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| Product |
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, |
| 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
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Recalling Firm/
Manufacturer |
Masimo Corporation
52 Discovery
Irvine CA 92618-3105
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Manufacturer Reason
for Recall |
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
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FDA Determined
Cause 2 |
Material/Component Contamination |
| Action |
On February 14, 2024 Masimo issued a "Urgent: Medical Device Recall Notice" via FedEx and US Mail to affected consignees. On February 29, 2024, Masimo issued an updated communication to provide additional information. Masimo's asked consignees to take the following actions:
" Please assess your inventory to confirm if you have Rad-G devices listed in Attachment 2-part number(s) and serial number(s).
" If you identify affected Rad-G¿ devices, please promptly remove them from use and follow the steps below.
" Contact Masimo Technical Services to request return of the affected part and serial number (s) for repair or replacement.
" Masimo s Technical Services is available Monday through Friday 6:00am -5:00pm PST for live assistance or 24 hours a day to leave a message and someone will contact you. Local contact information can be found at http://service.masimo.com. Complete Attachment 1, then email it to CustomerNotice@masimo.com, or Fax it to 1-949-297-7575 by MM DD, 2023. |
| Quantity in Commerce |
59 |
| 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. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database |
510(K)s with Product Code = DQA and Original Applicant = Masimo Corporation
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