Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0213-2015 — 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 c

U.S. FDA — Device Enforcement · United States · 2014-09-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0213-2015
Date of alert: 2014-09-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Masimo Corporation
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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