Recall Z-1984-2023— Masimo Corporation

Name: FDA recall Z-1984-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-21

Class II · Ongoing

Class II FDA medical device recall by Masimo Corporation, initiated 2023-04-21. It names one FDA 510(k) clearance: K033296. Product: Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794. Reason: TC-I tip clip sensor may produce readings outside the accuracy specification..

Recalling firm: Masimo Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-04-21
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K033296 — MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5VMasimo Corp.·cleared 2004-02-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794

Reason for recall

TC-I tip clip sensor may produce readings outside the accuracy specification.

Data sourced from openFDA. This site is unofficial and independent of the FDA.