Bayer Certegra Workstation Recalled for Fire and Smoke Risk
Bayer Healthcare is recalling 165 Certegra Workstations used with Medrad Stellant CT Injection Systems because they may produce smoke and sparks of fire.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a risk of fire and smoke, which constitutes a significant injury risk. This aligns with the rubric for 'Severe' severity, which includes significant injury reports or risks.
Plain-English summary
Bayer Healthcare is recalling 165 Certegra Workstations that are used in conjunction with the Medrad Stellant CT Injection System. The recall is due to a risk of thermal events, specifically the potential for the equipment to exhibit smoke and sparks of fire.
The affected systems were distributed worldwide, including nationwide in the United States and internationally to the United Arab Emirates, Australia, Canada, Germany, Spain, and the United Kingdom. The Medrad Stellant CT Injector System is intended for injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
Healthcare facilities should identify affected units by checking the serial numbers listed in the recall documentation. Consumers and medical staff should stop using the affected equipment and contact Bayer Healthcare for further instructions on the recall.
The recalled product
- Product
- Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic…
- Manufacturer
- Bayer Healthcare
- Affected units
- 165
Distribution
Distributed nationwide across the United States.
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