Recall Z-0213-2015 ยท DQA Oximeter
Masimo Corporation
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.
| Date | Nov 13, 2014 (initiated Sep 30, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| Action | 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 |
| Quantity | 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, Kuwait, Mexico, Netherlands, Poland, Portugal, South Korea, Spain, Switzerland, Turkey, and United Kin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121914 | MASIMO SET USPO2 PULSE OXIMETRY CABLE Masimo Corporation, Sep 7, 2012 |