Home / Recalls / Masimo Corporation / Z-0338-2016

Z-0338-2016 Class II Terminated

Recalled by Masimo Corporation — Irvine, CA

Recall Details

Product Type
Devices
Report Date
December 2, 2015
Initiation Date
October 28, 2015
Termination Date
May 18, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3476 units total (3322 units in US)

Product Description

rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check or continuous non-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate.

Reason for Recall

These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters.

Distribution Pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Costa Rica, France, Germany, Kuwait, Martinique, Netherlands, Norway, South Korea, and Turkey.

Code Information

2201 2407 2696 2697

Other recalls by Masimo Corporation

  • Z-1536-2024 Class II — Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, (February 15, 2024)
  • Z-1539-2024 Class II — Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, (February 15, 2024)
  • Z-1537-2024 Class II — Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, (February 15, 2024)
  • Z-1538-2024 Class II — Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, (February 15, 2024)
  • Z-1984-2023 Class II — Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 (April 21, 2023)
  • Z-1986-2023 Class II — Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 (April 21, 2023)
  • Z-1985-2023 Class II — Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 (April 21, 2023)
  • Z-1983-2023 Class II — Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 (April 21, 2023)
  • Z-0213-2015 Class II — Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line (September 30, 2014)
  • Z-1187-2013 Class II — Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories ar (March 13, 2013)