Reported Jan 29, 2014 · Terminated
Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any…
Medrad Mr Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medrad Mr Inc · 100 Global View Dr · Warrendale, PA · 15086-7601
Is this the product you have?
- 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.
- Lot codes and dates
P/N 301641Catalog #s 30119923011992W30119933011993W30119943011994W30119963011996W30142683014268Wwith multiple serial numbers
- Amount recalled
- 922 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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