Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
This recall has been terminated (originally issued January 27, 2013).
- Recall Initiated
- September 5, 2012
- Posted
- January 27, 2013
- Terminated
- October 22, 2013
- Recall Number
- Z-0742-2013
- Quantity
- 13 units
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.
Distribution
US Nationwide Distribution including the states of: VA, TN, FL, & TX
Lot / Code Info
p/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 OCOOO569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373
Root Cause
Device Design
Action Taken
Mindray DS USA Inc. sent an Urgent Product Corrective Action letter on September 5, 2012 via Fed Ex with delivery confirmation to all users. The letter identifies the affected product, problem and actions to be taken. Customers were instructed to contact their Mindray Service Representative at 1-800-288-2121 Monday through Friday 8:30-5:30 pm, to schedule a software upgrade.