Medical device recalls Moderate risk

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

Recall date
March 21, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1692-2015
FDA classification
Class II
Brand / firm
Smiths Medical ASD, Inc.
Sold / distributed
MN

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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