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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJune 10, 2005
Date PostedJune 25, 2005
Recall Status1 Terminated 3 on June 17, 2008
Recall NumberZ-0933-05
Recall Event ID 32384
510(K)NumberK992340 
Product Classification Oximeter - Product Code DQA
ProductRadical Handheld Pulse Oximeter
Code Information Serial numbers-- P3027 through P3148 and serial numbers less than or equal to 102999.
FEI Number 3001452206
Recalling Firm/
Manufacturer		 Masimo Corporation
40 Parker
Irvine CA 92618-1604
For Additional Information ContactJames Cronin
949-297-7000
Manufacturer Reason
for Recall		Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm.
FDA Determined
Cause 2		Other
ActionRecall 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.
Quantity in Commerce8,110
DistributionNationwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DQA
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