The Recall Desk
HighFDA (Devices)·Z-0810-2014·Announced 2014-01-29

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.

What this means for you

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 mo
Manufacturer
Medrad Mr Inc
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.