Z-0300-2007

BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This device is...

Name: Z-0300-2007 BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This device is...
Creator: Smiths Medical PM, Inc.
Published: 2006-11-06
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-11-06 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical PM, Inc. began a recall of BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This device is designed to provide full featured monitoring capabilities... on 2006-11-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0300-2007
Status: Terminated
Initiated: 2006-11-06
Posted: 2006-12-19
Terminated: 2008-10-09
Recalling firm: Abbott Medical
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.
Product code: DQA Oximeter
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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

Product code DQA

K981939Class IIAutocorr Plus; 3404 Oximeter/ecg MonitorBci Intl., Inc. / cleared 1998-08-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)