Reported May 8, 2013 · Terminated
Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive…
Masimo Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Masimo Corporation · Forty Parker · Irvine, CA · 92618
Is this the product you have?
- 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).
- Lot codes and dates
- Catalog Number
9190919391919192921292139218921992249282928528839194
- Catalog Number
- Amount recalled
- 42,908 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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