Recall Z-0213-2015— Masimo Corporation

Name: FDA recall Z-0213-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-30

Class II · Terminated

Class II FDA medical device recall by Masimo Corporation, initiated 2014-09-30, terminated 2016-03-28. It names one FDA 510(k) clearance: K121914. Product: Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile.. Reason: Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device..

Recalling firm: Masimo Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-09-30
Terminated: 2016-03-28
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K121914 — MASIMO SET USPO2 PULSE OXIMETRY CABLEMasimo Corporation·cleared 2012-09-07

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 SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile.

Reason for recall

Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device.

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