Skip to content
Recall Observatory FDA recall evidence

Device product

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).

Z-1187-2013

March 13, 2013

Class II

Product summary

Firm
Masimo Corporation
Event
Event 64812
Status
Terminated
Classification
Class II
Quantity
42,908 units
Official record key
device-enforcement:Z-1187-2013

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.