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Terminated

Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925754335.

FDA Recall Z-0833-05 · Posted 2005-05-12

Recalling FirmSmiths Medical PM, Inc.
Recall StatusTerminated
Product CodeDPS
Date Initiated2005-03-16
Date Terminated2006-12-31
Product Quantity15

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.

Firm Action

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

Distribution Pattern

CA and NY within US. Mexico, Argentina, Columbia, Chile, Brazil, Ecuador, Guatemala and Pakistan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030407ADVISOR, MODEL 9200Bci, Inc. · 2003-08-19K010770BCI ADVISOR VITAL SIGNS MONITOR (9200)Bci, Inc. · 2001-06-12K011177BCI ADVISOR VITAL SIGNS MONITOR (9200)Bci, Inc. · 2001-05-23K982279VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200Bci Intl., Inc. · 1998-09-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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