Vidco, Inc. recalls Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is in…

Recall date

November 8, 2015

Source

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

Recall number

Z-0582-2016

FDA classification

Class II

Brand / firm

Vidco, Inc.

Sold / distributed

US Nationwide distribution in the states of AZ, CA, MD, NM, NJ, and OH.

Why it was recalled

Testing at customer site showed unit Remote Patient Monitoring System MDP2040-0100 in a continuous trap condition, not allowing system to reset and reboot. Two customers recently complained of the system freezing and it could only be restarted if the user re-applied power.

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

What was recalled

Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU, CCU, PACU, Emergency, Telemetry Step-down and other areas where patient's physiological information are to be observed at one or more locations. Typical information displayed includes ECG and blood pressure waveforms and numeric values which as heart rate and systolic, mean and diastolic pressure. This device acts as the Central Monitor Station, it permits from one (1) to sixteen (16) bedside monitor(s) to be connected simultaneously.