The Recall Desk
ModerateFDA (Devices)·Z-0582-2016·Announced 2016-01-13

Vidco MDP 2000 Remote Patient Monitoring Systems Recalled for Freezing

Vidco, Inc. is recalling 59 MDP 2000 Series Remote Patient Monitoring Systems because they may freeze and fail to reset without a power cycle.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the issue involves a software freeze that requires a power cycle to resolve. No injuries, deaths, or hospitalizations are reported, and the hazard is a functional failure rather than a direct physical injury risk, fitting the Moderate criteria for low-risk operational issues.

Plain-English summary

Vidco, Inc. is recalling 59 units of the MDP 2000 Series Remote Patient Monitoring System, specifically part numbers MDP2040-0100, PGM340R3, or PGM340R4. The affected units are identified by specific serial numbers listed in the recall notice. These devices are intended for use in conjunction with patient monitoring equipment in areas such as ICUs, CCUs, and emergency departments, acting as a central monitor station for up to sixteen bedside monitors.

The recall was initiated after testing at a customer site revealed that an MDP2040-0100 unit was in a continuous trap condition, preventing the system from resetting and rebooting. Additionally, two customers reported that the system froze and could only be restarted by re-applying power. The affected units were distributed nationwide in Arizona, California, Maryland, New Mexico, New Jersey, and Ohio.

Healthcare facilities should identify any affected units by checking the serial numbers against the provided list. If a unit is affected, it should be removed from service and returned to Vidco, Inc. for repair or replacement according to the company's instructions.

The recalled product

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,
Manufacturer
Vidco, Inc.
Affected units
59

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • Serial numbers: 6533-6537
  • 6561
  • 6566-6581
  • 6539
  • 6540
  • 6558-6560
  • 6562
  • 6508-6528
  • 6563-6565
  • 6529
  • 6531
  • 6532
  • 6541
  • 6551
  • 6556
  • and 6557.

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically: