BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This device is designed to provid
FDA device recall Z-0300-2007 · posted 2006-12-19 · Terminated
Recall details
- Recalling firm
- Smiths Medical PM, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 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, Sing
- Date initiated
- 2006-11-06
- Date posted
- 2006-12-19
- Date terminated
- 2008-10-09
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR (K981939) | Bci Intl., Inc. | 1998-08-20 |