FDAFDA · Food and drugs·Recall number Z-0742-2013
Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
Published February 6, 2013 · Recall initiated: September 5, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mindray DS USA, Inc. d.b.a. Mindray North America
- Distributor
- US Nationwide Distribution including the states of: VA, TN, FL, & TX
- Lot
- p/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 OCOOO569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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