CLASS II Device recall · Reported 29 Jan 2014 · FDA Enforcement Report
Medrad Veris MR Monitor units The system is intended recalled
Medrad Mr is recalling Medrad Veris MR Monitor units The system is intended to monitor physiological parameters, distributed nationwide in the US. The recall was initiated on 21 Nov 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0810-2014
- FDA event ID
- 66996
- Recalling firm
- Medrad Mr, Warrendale, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Nov 2013
- FDA classified
- 23 Jan 2014
- Reported
- 29 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 21 Nov 2013 | Recall initiated by company | |
| 23 Jan 2014 | Classified by FDA | +63 days |
| 29 Jan 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution: US (nationwide) and Internationally to: Canada.
Questions about this recall
Why was it 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.
Which lots are affected?
P/N 301641, Catalog #s 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268, 3014268W, with multiple serial numbers.
Where was it sold?
Worldwide Distribution: US (nationwide) and Internationally to: Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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