Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MEDRAD¿ Stellant CT Injector System with Certegra Workstation Recalled by Medrad Inc dba Bayer R&I Due to The root cause investigation showed that the under-volume...

Date: September 20, 2013
Company: Medrad Inc dba Bayer R&I
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medrad Inc dba Bayer R&I directly.

Affected Products

MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.

Quantity: 133

Why Was This Recalled?

The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not being sent to the injector head. This may create a non-optimal priming condition that could lead to under-infusion.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medrad Inc dba Bayer R&I

Medrad Inc dba Bayer R&I has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report