Smiths Medical ASD Inc. recalls BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The dif…

Recall date

November 29, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2379-2018

FDA classification

Class II

Brand / firm

Smiths Medical ASD Inc.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of CO and MT. Foreign distribution was to Armenia.

Why it was recalled

Some printing modes on the devices may not function properly (tabular data printing, real-time continuous printouts, and automatic interrupt print feature).

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

What was recalled

BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installed or not installed.) Product Usage: The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 lead/5 lead), impedance respiration (RSP), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), two invasive blood pressures (P1 and P2), and two temperature channels (T1 and T2). Capnography (ETCO2, inCO2, RR), a two-inch internal, graphical/alphanumeric printer and a battery are provided as options. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The device will provide fast, reliable measurements on patients ranging from neonate to adults when using the appropriate BCI accessories. The impedance respiration and capnography parameters are available in adult and pediatric mode only and are not intended for neonatal monitoring. The monitor may be connected to the Life Sensing Instrument Company, Inc. HTS 820 Central Station for remote monitoring of patient status. The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor.