FDA Medical Device Recalls (openFDA)
Medrad Mr Inc: 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.
- Recall number
- Z-0810-2014
- Recalling firm
- Medrad Mr Inc
- 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.
- Status
- Terminated
- Initiated
- 2013-11-21
- Posted
- 2014-01-23
- Terminated
- 2015-03-30
- 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.
- Root cause
- Device Design
- Action
- The firm, Bayer HealthCare, sent a "MEDICAL DEVICE FIELD CORRECTIVE ACTION" letter dated November 21, 2013 via certified mail to its users/customers. The letter described the product, problem and actions to be taken. The firm stated that, "You may choose to continue to use your Veris units but you MUST be vigilant about this potential issue. Should a shutdown occur, the system can be quickly restarted by pressing the POWER button. If this problem does occur, we ask that you report this immediately to Bayer Customer Support at 1-877-229-3767." The customers were instructed to verify the serial number on your Medrad Veris unit(s). If this problem does occur, report this immediately to Bayer Customer Support at 1-877-229-3767. The customers were also instructed to fill out and fax back the attached form. Bayer Service Representative will then be in touch to schedule an appointment to come and replace your main board, at no cost to you. Bayer also informed their customers that based on the maximum inventory that can be produced by the supplier, they anticipate that this Field Corrective Action will take up to six months. If you have questions, please contact our Customer Support team at 1-877-229-3767.
- Quantity
- 922 units
- Distribution
- Worldwide Distribution: US (nationwide) and Internationally to: Canada.
- Lot, serial or model codes
- P/N 301641, Catalog #s 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268, 3014268W, with multiple serial numbers.
- 510(k) numbers
- ["K042569"]
- PMA numbers
- not on file
- Product code
- MWI
- Firm FEI
- 3006316319
- Firm city
- Warrendale
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28