Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654225. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654225.
Brand
Smiths Medical PM, Inc.
Lot Codes / Batch Numbers
serial no. 706692007
Products Sold
serial no. 706692007
Smiths Medical PM, Inc. is recalling Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 92 due to Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 (%).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, NY
Page updated: Jan 10, 2026