Product Description Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).

Recall Number Z-1187-2013

Classification Class II

Code Info Catalog Number 9190 9193 9191 9192 9212 9213 9218 9219 9224 9282 9285 2883 9194

Product Distributed Qty 42,908 units

Reason For Recall Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.

Event Id 64812

Product Type Devices

Status Ongoing

Recalling Firm Masimo Corporation, Irvine, CA, USA

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-03-13

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia