FDA Device

Radical Handheld Pulse Oximeter

Hazard

Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm.

What You Should Do

Remedy

Recall was by letter to all customers who received units made before 12/11/01. They are to return for repair or have them fixed by an Authorized Masimo Service Representative.

Products

Radical Handheld Pulse Oximeter
Brand
Masimo Corporation
UPC
Serial numbers-- P3027 through P3148 and serial numbers less than or equal to 102999.

Units Affected

8,110