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.
FDA Recall Z-0300-2007 · Posted 2006-12-19
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Recalling FirmSmiths Medical PM, Inc.
Recall StatusTerminated
Product CodeDQA
Date Initiated2006-11-06
Date Terminated2008-10-09
Product Quantity207
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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