Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is int
FDA device recall Z-0582-2016 · posted 2016-01-04 · Terminated
Recall details
- Recalling firm
- Vidco, Inc.
- 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.
- Action taken
- 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
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MSX
- Quantity affected
- 59 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, MD, NM, NJ, and OH.
- Date initiated
- 2015-11-08
- Date posted
- 2016-01-04
- Date terminated
- 2016-08-16
- Location
- Beaverton, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MDP2000 MEDICAL DATA PROCESSOR (K972880) | Vidco, Inc. | 1997-10-22 |