Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 92
FDA device recall Z-0826-05 · posted 2005-05-12 · Terminated
Recall details
- Recalling firm
- Smiths Medical PM, Inc.
- Reason for recall
- Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). The % CO values displayed will be lower than the actual CO2 value.
- Action taken
- On March 16, 2005, customers were emailed Safety Action Bulletin 05-003 informing them of the low CO2 (End Tidal and Inspired) measurements in percent (%) and urging them to use mmHg or kPa as the unit of measurement . In addition, a Technical Worksheet will be distributed to customers who request a software upgrade. The Technical Worksheet will instruct them how to perform the software upgrade which corrects the CO2 measurements (End Tidal and Inspired) in percent (%).
- Root cause
- Other
- Status
- Terminated
- Product code
- DPS
- Quantity affected
- 4
- Distribution
- CA and NY within US. Mexico, Argentina, Columbia, Chile, Brazil, Ecuador, Guatemala and Pakistan.
- Date initiated
- 2005-03-16
- Date posted
- 2005-05-12
- Date terminated
- 2006-12-31
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVISOR, MODEL 9200 (K030407) | Bci, Inc. | 2003-08-19 |
| BCI ADVISOR VITAL SIGNS MONITOR (9200) (K010770) | Bci, Inc. | 2001-06-12 |
| BCI ADVISOR VITAL SIGNS MONITOR (9200) (K011177) | Bci, Inc. | 2001-05-23 |
| VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 (K982279) | Bci Intl., Inc. | 1998-09-25 |