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Class 3 Device Recall BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor |
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Date Initiated by Firm |
July 18, 2007 |
Date Posted |
September 21, 2007 |
Recall Status1 |
Terminated 3 on October 31, 2008 |
Recall Number |
Z-1240-2007 |
Recall Event ID |
38472 |
510(K)Number |
K981939
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Product Classification |
Monitor - Product Code DQA
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Product |
BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001 (including S) and 3404002 (including E,F, G, and S) Smiths Medical- a part of Smiths Group plc |
Code Information |
Catalog number/ serial number: 3404001/AI05110052/ AI05120000/ AI05120011/ AI05120012/ AI05120013/ AI05120018/ AI06060015/ AI06070047/ AI06100004/ AI06100005/ AI06100006/ , 3404001S/AI05110000/ AI05110001/ AI05110002/ AI05110003/ AI05110004/ AI05110005/ AI05110006/ AI05110007/ AI05110008/ AI05110009/ AI05110010/ AI05110011/ AI05110012/ AI05110013/ AI05110014/ AI05110015/ AI05110016/ AI05110017/ AI05110018/ AI05110019/ AI05110020/ AI05110021/ AI05110022/ AI05110023/ AI05110024/ AI05110025/ AI05110026/ AI05110027/ AI05110028/ AI05110029/ AI05110030/ AI05110031/ AI05110032/ AI05110033/ AI05110034/ AI05110035/ AI05110036/ AI05110037/ AI05110038/ AI05110039/ AI05120010/ AI05120016/ AI05120017/ AI05120019/ AI06010042/ AI06010043/ AI06060003/ AI06060004/ AI06060005/ AI06060006/ AI06060007/ AI06060008/ AI06060009/ AI06060010/ AI06060011/ , 3404002/AI05090021/ AI05090024/ AI05110049/ AI05120015/ AI06010035/ AI06010036/ AI06010049/ AI06040000/ AI06040001/ AI06040002/ AI06040003/ AI06040004/ AI06040005/ AI06040006/ AI06040007/ AI06040008/ AI06040009/ AI06040010/ AI06040011/ AI06040012/ AI06040013/ AI06040014/ AI06040015/ AI06040016/ AI06040017/ AI06040018/ AI06040020/ AI06060012/ AI06060013/ AI06060014/ AI06060017/ AI06060018/ AI06060019/ AI06060020/ AI06070037/ AI06070038/ AI06070039/ AI06070040/ AI06070042/ AI06070043/ AI06070044/ AI06070045/ AI06090053/ AI06100011/ AI06100012/ AI07010057/ AI07010058/ , 3404002E/AI05110040 AI05110041/ AI05110042/ AI05120001/ AI05120002/ AI05120005/ AI05120006/ AI05120007/ AI05120008/ AI05120009/ AI05120024/ AI06010041/ AI06010044/ AI06010045/ AI06010046/ AI06010048/ AI06040019/ AI06040023/ AI06040024/ AI06070041/ AI06070046/ AI06070048/ AI06070049/ AI06090050/ AI06090051/ , 3404002F/AI07010067/ AI07010068/ , 3404002G/AI05110050/ AI05110051/ AI05120003/ AI05120004/ AI06060021/ AI06060022/ AI06060023/ AI06070035/ AI06070036/ AI06090054/ AI06090055/ AI06090056/ AI06090057/ AI06090058/ AI06100008/ AI06100009/ AI06100010/ AI06100018/ , 3404002S/AI05110043/ AI05110044/ AI05110045/ AI06010037/ AI06010038/ AI06010039/ AI06010040/ AI06060000/ AI06060001/ AI06060002/ AI06060016/ AI06090052/ AI06100019/ AI06100020/ AI06100021/ AI06100022/ AI06100023/ AI06100024/ AI07010050/ AI07010051/ |
Recalling Firm/ Manufacturer |
Smiths Medical PM, Inc. N7w22025 Johnson Dr Waukesha WI 53186-1856
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For Additional Information Contact |
262-542-3100
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Manufacturer Reason for Recall |
Phantom pacer spikes caused by a damaged resistor.
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FDA Determined Cause 2 |
Other |
Action |
Customers will be notified via a Customer Information Bulletin CIB Tracking Number: 07-CIB 12, July 18,2007 requesting them to evalute the functionality of their monitor (s). If the monitor does not exhibit any false pace detect makers when pace detect is enabled and respiration is disabled, no further action is required. If it does exhibit false pace detect they will be instructed to contact the Smiths Medical PM, Inc service department. At that time Technical Worksheet, 07-TW02, will be provided. The consignee will need to verify they are capable of perfoming the Technical Worksheet provided. The Smiths Medical PM. Inc. Service Manger will veirfy if the consignee is capable of performing the rework. |
Quantity in Commerce |
178 |
Distribution |
World wide: USA including states of KY, MS, PA, LA, and PR and countries of Poland, Mexico, Kuwait, Taiwan, Singapore, Hon Kong, India, Bolivia, Colombia, Chile, Argentia, Brunei Darssalam, Israel, Greece, Romania, Germany, The Netherlands, France, Great Britain, Spain, Brazil, Russia, China. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = DQA and Original Applicant = BCI INTL., INC.
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