Recall Z-1985-2023 ยท DQA Oximeter
Masimo Corporation
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
| Date | Jun 21, 2023 (initiated Apr 21, 2023) |
| Status | Open, Classified |
| Reason | TC-I tip clip sensor may produce readings outside the accuracy specification. |
| Root cause | Nonconforming Material/Component |
| Action | On 5/17/2023, Masimo issued a Urgent: Medical Device Recall Notice via FedEx. Masimo asked consignees to take the following actions: 1. Contact Masimo Technical Services to request return of the affected part and lot number(s) for replacements and/ or if you have part numbers or lot numbers not included in this communication and have questions about those parts. 2. 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.ma |
| Quantity | 443,799 units |
| Distribution | US: AK , AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, China, Co |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051212 | MODIFICATION TO LNCS OXIMETRY SENSORS Masimo Corporation, Jul 12, 2005 |