Z-0830-05

Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A)...

Name: Z-0830-05 Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A)...
Creator: Smiths Medical PM, Inc.
Published: 2005-03-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-03-16 / Terminated

FDA source

Smiths Medical PM, Inc. began a recall of Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654325 on 2005-03-16. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0830-05
Status: Terminated
Initiated: 2005-03-16
Posted: 2005-05-12
Terminated: 2006-12-31
Recalling firm: Abbott Medical
Product: Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654325.
Product code: DPS Electrocardiograph
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.
FDA root cause: Other
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 (%).
Quantity in commerce: 6
Distribution: CA and NY within US. Mexico, Argentina, Columbia, Chile, Brazil, Ecuador, Guatemala and Pakistan.
Product codes and lots: serial no. 706330001, 706330002, 706330003, 706330004, 706330005 and 706431007.

Product code DPS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)