Medrad Recalls Veris MR Monitor Units Due to Faulty Main Board
Medrad is recalling 922 Veris MR Monitor units because a faulty main board may cause unexpected system shutdowns, resulting in the loss of vital signs information.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may fail during use, leading to the loss of vital signs monitoring. This fits the rubric for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Medrad MR Inc is recalling 922 units of the Medrad Veris MR Monitor. The recall is due to a potential defect in the main board (P/N 301641) installed in some of these units.
The faulty main board could lead to an unexpected shutdown of the system while it is in use. This failure would result in the loss of vital signs information from the monitor, which is intended to monitor physiological parameters of patients in healthcare environments.
The affected units were distributed nationwide in the United States and internationally to Canada. The specific units are identified by P/N 301641 and various catalog numbers including 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268, and 3014268W. Healthcare providers should check their inventory for these specific part and catalog numbers.
The recalled product
- 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…
- Manufacturer
- Medrad Mr Inc
- Category
- Medical Device — Patient Monitor
- Affected units
- 922
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- P/N 301641
- Catalog #s 3011992
- 3011992W
- 3011993
- 3011993W
- 3011994
- 3011994W
- 3011996
- 3011996W
- 3014268
- 3014268W
- with multiple serial numbers.
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · device failure
See all →- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCoaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
Similar recalls
- SevereMedrad Recalls DC Power Cables for Veris MR Vital Signs Monitor
FDA (Devices) · 2013-07-03
- HighMindray V-Series Patient Monitoring System Recalled for ECG Interpretation Errors
FDA (Devices) · 2014-07-23
- HighInnokas Medical Recalls CARESCAPE VC150 Vital Signs Monitors for Shutdown Defect
FDA (Devices) · 2015-11-18
- HighMindray Recalls V Series Patient Monitors Due to Software Anomalies
FDA (Devices) · 2012-09-05
- HighMindray Recalls V Series Patient Monitors Due to Power Pin Issue
FDA (Devices) · 2013-12-04
- HighInnokas Medical Recalls CARESCAPE VC150 Vital Signs Monitors for Software Error
FDA (Devices) · 2016-08-31