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U.S. Department of Health and Human Services

Class 2 Device Recall BCI 3180 Pulse Oximeter

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 Class 2 Recall
BCI 3180 Pulse Oximeter
see related information
Date Posted August 15, 2008
Recall Status1 Open
Recall Number Z-1619-2008
Recall Event ID 47495
Premarket Notification
510(K) Number
K020350 
Product Classification Oximeter - Product Code DQA
Product BCI ®3180 Oximeter - Patient monitoring medical device, Manufactured by Smiths Medical PM, Inc. For continuous patient monitoring of blood oxygen levels, pulse rate and pulse strength measurements. It is only used in hospital or clinical settings or emergency response environments.
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Recalling Firm/
Manufacturer
Smiths Medical PM, Inc.
N7w22025 Johnson Dr
Waukesha, Wisconsin 53186-1856
Manufacturer Reason
for Recall
The Smith Medical PM, Inc. BCI ¿¿3180 Pulse Oximeter tantalum capacitors C38, C72, C74, and C98 were installed backwards during assembly at the board manufacturer. This exposes the components to reverse polarity voltages that may lead to their pre-mature failure. As a result, the identified monitors may exhibit failure modes such as the monitor may shut down and not produce alarms or signals to
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Consignees were contacted by an URGENT: Product Safety Information Voluntary Recall Notification letter dated March 11, 2008 with attached Safety Action Bulletin 08-SAB01 dated February 27, 2008 and email between March 7 and March 13, 2008. The consignees will need to return the device to be evaluated in the Smiths Medical PM, Inc.
Quantity in Commerce 900
Distribution Class II Recall - Worldwide Distribution --- USA including states of GA, AL, IL, TX, MI, VA, IA, TN, PA, NC, HI, NY, FL, AZ, OH, CA, MS, UT and Countries: Argentina, Bangladesh, Iran, Thailand, Mexico, India, Germany, Guatemala, Pakistan, Chile, Colombia, Brazil, Saudi Arabia, Morocco, Kuwait, Trinidad and Tobago, Ecuador, Paraguay, Uruguay, Canada, Poland, Portugal, Peru, Qatar, Cyprus, Greece, Italy, Spain, United Arab Emirates, Israel.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQA and Original Applicant = BCI, INC.
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