Product Wiki · Recalls · U.S. FDA — Device Enforcement

Remote Patient Monitoring System, MDP 2000 Series, Part Numbers… — recall Z-0582-2016

U.S. FDA — Device Enforcement · United States · 2015-11-08 · Class II

As described by U.S. FDA — Device Enforcement: 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

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0582-2016
Date of alert
2015-11-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Vidco, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide distribution in the states of AZ, CA, MD, NM, NJ, and OH.
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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