Recall Z-0810-2014— Medrad Mr Inc
Class II · Terminated
Class II FDA medical device recall by Medrad Mr Inc, initiated 2013-11-21, terminated 2015-03-30. It names one FDA 510(k) clearance: K042569. Product: 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.. Reason: 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..
- Recalling firm
- Medrad Mr Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-21
- Terminated
- 2015-03-30
- Firm location
- Warrendale, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.