FDAFDA · Food and drugs·Recall number Z-0810-2014
Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas monitoring, system alarms, and patient analysis will be available to the care provider from the monitor.
Published January 29, 2014 · Recall initiated: November 21, 2013
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
The main board, P/N 301641, installed in some Medrad Veris MR Monitor units may be faulty and could lead to unexpected shutdown of the system while in use, resulting in the loss of vital signs information from the monitor.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medrad Mr Inc
- Distributor
- Worldwide Distribution: US (nationwide) and Internationally to: Canada.
- Lot
- P/N 301641, Catalog #s 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268, 3014268W, with multiple serial numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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