FDAFDA · Food and drugs·Recall number Z-0582-2016
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.
Published January 13, 2016 · Recall initiated: November 8, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Vidco, Inc.
- Distributor
- US Nationwide distribution in the states of AZ, CA, MD, NM, NJ, and OH.
- Lot
- Serial numbers: 6533-6537, 6561, 6566-6581, 6539, 6540, 6558-6560, 6562, 6508-6528, 6563-6565, 6529, 6531, 6532, 6541, 6551, 6556, and 6557.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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