Reported Jun 10, 2015 · Terminated

Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.

Smiths Medical ASD, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Smiths Medical ASD, Inc. · 1265 Grey Fox Rd · Saint Paul, MN · 55112-6929

Is this the product you have?

  • Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
Lot codes and dates
  • Serial Numbers4059587
  • through 4059591 UPDATED 4-20-2015additional
  • devices affected have serial numbers
    • 4059949
    • 4059950
    • 4059951
    • 4059952
    • 4059953
    • 4059954
    • 4059955
    • 4059957
    • 4059958 and 4059960
Amount recalled
5 UPDATE 4-20-2015 to include 10 additional devices

Where it was sold

Why it was recalled

The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in data formatting issues or incorrect data being transmitted in or out of the serial port into a data collection system.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 20, 2015 · Data as of Sep 19, 5:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.