Recall Z-0582-2016 ยท MSX System, Network And Communication, Physiological Monitors
Vidco, Inc.
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
| Date | Jan 4, 2016 (initiated Nov 8, 2015) |
| Status | Terminated |
| 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. |
| Root cause | 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 monit |
| Quantity | 59 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, MD, NM, NJ, and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972880 | MDP2000 MEDICAL DATA PROCESSOR Vidco, Inc., Oct 22, 1997 |