Recall Z-1536-2024 ยท DQA Oximeter
Masimo Corporation
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
| Date | Apr 12, 2024 (initiated Feb 15, 2024) |
| Status | Open, Classified |
| Reason | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. |
| Root cause | 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 nu |
| Quantity | 443 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, Aus |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213676 | Masimo Rad-G with Temperature Masimo Corporation, Apr 16, 2023 |