Remote Patient Monitoring System — Class II medical device recall Z-0582-2016
Terminated recall by Vidco, Inc., reported 2016-01-13, distributed nationwide. Testing at customer site showed unit Remote Patient Monitoring System MDP2040-0100 in a continuous trap condit
| Recall number | Z-0582-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vidco, Inc., Beaverton, OR, United States |
| Recall initiated | 2015-11-08 |
| Classified | 2016-01-04 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 59 units |
| Serial numbers | 6508-6528, 6529, 6531, 6532, 6533-6537, 6539, 6540, 6541, 6551, 6556, 6557, 6558-6560, 6561, 6562, 6563-6565, 6566-6581 |
| Model numbers | MDP2000, MDP2040-0100, PGM340R3, PGM340R4 |
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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.