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Terminated

Radical Handheld Pulse Oximeter

FDA Recall Z-0933-05 · Posted 2005-06-25

Recalling FirmMasimo Corporation
Recall StatusTerminated
Product CodeDQA
Date Initiated2005-06-10
Date Terminated2008-06-17
Product Quantity8,110

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992340MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEMasimo Corp. · 1999-10-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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