Z-1187-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2013
- Initiation Date
- March 13, 2013
- Termination Date
- June 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42,908 units
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).
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.
Code Information
Catalog Number 9190 9193 9191 9192 9212 9213 9218 9219 9224 9282 9285 2883 9194