Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
FDA device recall Z-1986-2023 · posted 2023-06-21 · Open, Classified
Recall details
- Recalling firm
- Masimo Corporation
- Reason for recall
- TC-I tip clip sensor may produce readings outside the accuracy specification.
- Action taken
- 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.masimo.com. 3. Complete Attachment 1, then email it to CustomerNotice@masimo.com, or Fax it to 1-949-297-7575 by MM DD, 2023. 4. Any adverse reaction or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program online, by regular mail or by fax.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- DQA
- Quantity affected
- 123,745 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,
- Date initiated
- 2023-04-21
- Date posted
- 2023-06-21
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO LNCS OXIMETRY SENSORS (K051212) | Masimo Corporation | 2005-07-12 |