FDAFDA · Food and drugs·Recall number Z-0837-2015
DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters.
Published December 31, 2014 · Recall initiated: October 6, 2014
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 that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors display.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Distributor
- Distributed to the states of AL, CA, CO, FL, GA, IA, IL, IN, LA. MA, MO, MS, MT, NC, ND, NY, OH, PA, SC, TX, VA, WA and WV.
- Lot
- DPM 6 - PN: C-047-000199-00 and DPM 7 - PN: C-047-000200-00, IBP Module P/N: 6800-30-50485
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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