Recall Z-0582-2016— Vidco, Inc.

Name: FDA recall Z-0582-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-08

Class II · Terminated

Class II FDA medical device recall by Vidco, Inc., initiated 2015-11-08, terminated 2016-08-16. It names one FDA 510(k) clearance: K972880. Product: 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.. Reason: 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..

Recalling firm: Vidco, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-11-08
Terminated: 2016-08-16
Firm location: Beaverton, OR, United States

510(k) clearances named in this recall

1 on FDA's record

K972880 — MDP2000 MEDICAL DATA PROCESSORVidco, Inc.·cleared 1997-10-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.