FDA recall Z-2379-2018

Smiths Medical ASD Inc. · Class II · device

Product

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 ne

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2017-11-29
Report date
2018-07-18
Termination date
2018-07-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2379-2018