Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654325.
- Company
- Smiths Medical Pm, Inc.
- Recall Initiated
- March 16, 2005
- Posted
- May 12, 2005
- Terminated
- December 31, 2006
- Recall Number
- Z-0830-05
- Quantity
- 6
- Firm Location
- Waukesha, WI
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.
Distribution
CA and NY within US. Mexico, Argentina, Columbia, Chile, Brazil, Ecuador, Guatemala and Pakistan.
Lot / Code Info
serial no. 706330001, 706330002, 706330003, 706330004, 706330005 and 706431007.
Root Cause
Other
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 (%).