Advisor Vital Signs Monitor (model 9200) with Capnography… recallZ-0830-05 · Smiths Medical PM, Inc. · initiated Mar 16, 2005

Why it was recalled

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 category: Other

What the company is doing

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 (%).

Recall details

Recall number

Z-0830-05

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Mar 16, 2005

Posted by the FDA

May 12, 2005

Recalling firm

Smiths Medical PM, Inc.

Quantity

6

Product code

DPS

FDA submissions

K010770, K011177, K030407, K982279

Distribution

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

Product description

Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654325.

Other devices under the same FDA submission

2 devices cleared under K010770, K011177, K030407, K982279 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• BCI WW1100

  Icu Medical, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  1 recall2 reports
• BCI 920654230A

  Icu Medical, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  2 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 31505).

• Z-0824-05 · Terminated
  Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654225.
• Z-0825-05 · Terminated
  Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654335.
• Z-0826-05 · Terminated
  Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925474325.
• Z-0827-05 · Terminated
  Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925554325.
• Z-0828-05 · Terminated
  Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925574325.
• Z-0829-05 · Terminated
  Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654220.
• Z-0831-05 · Terminated
  Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674320.
• Z-0832-05 · Terminated
  Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674335.
• Z-0833-05 · Terminated
  Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925754335.
• Z-0834-05 · Terminated
  Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925774325.
• Z-0835-05 · Terminated
  Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 92E654325.