RecallDepth

Radical Handheld Pulse Oximeter

Company
Masimo Corporation
Recall Initiated
June 10, 2005
Posted
June 25, 2005
Terminated
June 17, 2008
Recall Number
Z-0933-05
Quantity
8,110
Firm Location
Irvine, CA

Reason for Recall

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

Distribution

Nationwide and Korea, Hong Kong, Canada, New Zealand, Thailand, Argentina, Portugal, Malaysia, Ireland, Australia, japan, France, El Salvador, South Africa, UAE-Saudi Arabia, Germany, Mexico, Unitied Kingdom, Singapore, Germany, Kuwait, Chile, Spain, Iceland, Italy, Poland, Sweden, Norway, Venezuela, Lithuania, Czech Republic, Belgium, Neterlands, Austria, Switzerland, Egypt, Greece, France Taiwan.

Lot / Code Info

Serial numbers-- P3027 through P3148 and serial numbers less than or equal to 102999.

Root Cause

Other

Action Taken

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.

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