Recall Z-1539-2024— Masimo Corporation

Name: FDA recall Z-1539-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-15

Class II · Ongoing

Class II FDA medical device recall by Masimo Corporation, initiated 2024-02-15. It names one FDA 510(k) clearance: K213676. Product: Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,. Reason: Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring..

Recalling firm: Masimo Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-02-15
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K213676 — Masimo Rad-G with TemperatureMasimo Corporation·cleared 2023-04-16

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 Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,

Reason for recall

Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

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