Z-0742-2013 Class II Terminated
FDA device recall Z-0742-2013 was initiated by Mindray DS USA, Inc. d.b.a. Mindray North America on September 5, 2012 and is designated Class II. Reason for recall: Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available. The recall status is terminated (terminated October 22, 2013). Affected quantity: 13 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 6, 2013
- Initiation Date
- September 5, 2012
- Termination Date
- October 22, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
Product Description
Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
Reason for Recall
Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.
Distribution Pattern
US Nationwide Distribution including the states of: VA, TN, FL, & TX
Code Information
p/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 OCOOO569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373