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U.S. Department of Health and Human Services

Class 2 Device Recall Remote Patient Monitoring System

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  Class 2 Device Recall Remote Patient Monitoring System see related information
Date Initiated by Firm November 08, 2015
Date Posted January 04, 2016
Recall Status1 Terminated 3 on August 16, 2016
Recall Number Z-0582-2016
Recall Event ID 72794
510(K)Number K972880  
Product Classification System,network and communication,physiological monitors - Product Code MSX
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.
Code Information Serial numbers: 6533-6537, 6561, 6566-6581, 6539, 6540, 6558-6560, 6562, 6508-6528, 6563-6565, 6529, 6531, 6532, 6541, 6551, 6556, and 6557.
Recalling Firm/
Manufacturer		 Vidco, Inc.
6175 Sw 112th Ave
Beaverton OR 97008-4838
For Additional Information Contact Dan Gibson
503-641-1804
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action The firm began notifying consignees on Nov. 8, 2015 and followed up with the Advisory Notice letter, dated November 10, 2015. VIDCO identified the root cause and has corrected software that is currently going through validation. This software will be made available for updating the MDP2040-0100 as soon as it is released. The units may be updated on-site with the software program that will become available on the File Transfer Protocol (FTP) site. If you are unable to perform the procedure yourself, VIDCO will assist you in this effort. The current software version can still be used for monitoring as long as the user confirms the displays are still dynamically writing waves to the screen (i.e. waves will be changing in real-time). Consignees with questions can call (503) 641-1804 or 800-638-4326, or send email to sales@vidcoinc.com
Quantity in Commerce 59 units
Distribution US Nationwide distribution in the states of AZ, CA, MD, NM, NJ, and OH.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MSX and Original Applicant = VIDCO, INC.
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