Masimo Corporation: Medical Device Recall in 2013 - (Recall #: Z-1187-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: March 13, 2013

Date Posted: May 8, 2013

Recall Number: Z-1187-2013

Event ID: 64812

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.

Status: Terminated

Product Quantity: 42,908 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated