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Class 2 Device Recall BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor |
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Date Initiated by Firm |
November 06, 2006 |
Date Posted |
December 19, 2006 |
Recall Status1 |
Terminated 3 on October 09, 2008 |
Recall Number |
Z-0300-2007 |
Recall Event ID |
36786 |
510(K)Number |
K981939
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Product Classification |
patient monitor - Product Code DQA
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Product |
BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This device is designed to provide full featured monitoring capabilities in a tabletop design. The system features an ECG cable interface, an SpO2 probe interface, display of patient and waveform data via an EL panel, power status LED, and the function keypad area consisting of six keys (on/off, waveform/trend, alarm silence, menu/enter, up arrow & down arrow). The monitor has a serial port that is used for data communications to a printer or computer and for analog outputs. |
Code Information |
Catalog Number 3404001, serial number ranges: AI05070075 - AI05070099, AI05090000 - AI05090024, AI05110040 - AI05110059, AI05120000 - AI05120010, AI05120013 - AI05120024, AI06010035 - AI06010049, AI06040000 - AI06040024, AI06060000 - AI06060014, AI06060016 - AI06060024, AI06070035 - AI06070041, AI06070043 - AI06070045. Catalog Number 3401001S, serial number range: AI05110000 - AI05110039 |
Recalling Firm/ Manufacturer |
Smiths Medical PM, Inc. N7w22025 Johnson Dr Waukesha WI 53186
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Manufacturer Reason for Recall |
An error occurred at the board manufacturing site which may affect the following parameters: - An electrical noise observed on the SpO2 pleth waveform generating and displaying erratic heart rates. % SpO2 reading displays dashes. - The ECG waveform may appear noisy, ECG readings appear accurate. -Respiration waveform may appear noisy and the respiration readings will be displayed as dashes.
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FDA Determined Cause 2 |
Other |
Action |
An Safety Action Bulletin, dated 11/03/2006 was sent to affected customers describing the issue, what parameters are affected on the monitor and provides informatin on how to have the monitor repaired. Smiths Medical MDPM requests that an acknowledgement form be returned to them. |
Quantity in Commerce |
207 |
Distribution |
Worldwide, including USA, Puerto Rico, Argentina, Bolivia, Brunei, Chile, China, Columbia, Czech Republic, Germany, Greece, Hong Kong, India, Israel, Kuwait, Mexico, Netherlands, Poland, Romania, Singapore, Spain, Taiwan, and United Kingdom. |
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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