Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasiv

FDA device recall Z-0213-2015 · posted 2014-11-13 · Terminated

Recall details

Recalling firm

Masimo Corporation

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.

Action taken

An "Urgent: Advisory Notice," dated 09/30/2014, was sent to customers. The letter informed customers of the problem identified and the actions to be taken. Customers were instructed to evaluate their inventory of Oximetry Cable(s) using the following method: Use the Oximetry Cable to take a SpO2 measurement on a healthy individual with an expected SpO2 value above 90% or review SpO2 measurements take with the Oximetry Cable and verify that measurement results were consistent with expected SpO2 values. If the SpO2 measurement(s) is consistent with expected SpO2 value, the Oximetry Cable is not affected and can continue to be used. Customers are instructed to complete and return Attachment 2, Tracking/Verification Form, to Masimo in order to document that the Oximetry Cable(s) is functioning as intented. If the assessment results in SpO2 measurement that is not consistent with expected SpO2 value, then the Oximetry Cable should be removed from service, segregated and returned to Masimo. Customers are instructed to call 1-800-326-4890 and select option 2 for Technical Services. Customers are to determine with Technical Services whether they will return the affected Oximetry Cable(s) to Masimo for replacement or refund. If returning for replacement customers are suppose to obtain a Return Material Authorization Number (RMA number).

Root cause

Employee error

Status

Terminated

Product code

DQA

Quantity affected

21,754 units (21,222) in the U.S. and Puerto Rico)

Distribution

Worldwide distribution including; nationwide (U.S. and Puerto Rico) and the countries of Argentina, Austria, Brazil, Canada, China, Denmark, France, Gernany, Hong Kong, India, Italy, Japan, Jordan, Ku

Date initiated

2014-09-30

Date posted

2014-11-13

Date terminated

2016-03-28

Location

Irvine, CA

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