Z-0810-2014 Class II Terminated
FDA device recall Z-0810-2014 was initiated by Medrad Mr Inc on November 21, 2013 and is designated Class II. 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 informa… The recall status is terminated (terminated March 30, 2015). Affected quantity: 922 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2014
- Initiation Date
- November 21, 2013
- Termination Date
- March 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 922 units
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.
Distribution Pattern
Worldwide Distribution: US (nationwide) and Internationally to: Canada.
Code Information
P/N 301641, Catalog #s 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268, 3014268W, with multiple serial numbers.