Z-1187-2013 Class II Terminated
FDA device recall Z-1187-2013 was initiated by Masimo Corporation on March 13, 2013 and is designated Class II. 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. The recall status is terminated (terminated June 10, 2015). Affected quantity: 42,908 units.
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