Bayer Medical Care Recalls MAVIG Portegra Overhead Counterpoise Systems
Bayer Medical Care is recalling MAVIG Portegra and Portegra2 Overhead Counterpoise Systems because the head mount knob may not be properly tightened, causing the injector head to become loose or fall.
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 risk-of-harm product where the injector head may fall, but the source text does not report any injuries or illnesses, meeting the criteria for a High severity score.
Plain-English summary
Bayer Medical Care, Inc. is recalling the MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with specific Medrad injection systems. The recall involves 16,656 units distributed nationwide in the United States and to numerous foreign countries.
The recall is being issued because if the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged. This can cause the injector head to become loose or fall.
Healthcare facilities and users of these systems should contact Bayer Medical Care for further instructions on how to address the issue.
The recalled product
- Product
- MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL…
- Manufacturer
- Bayer Medical Care, Inc.
- Hazard
- Affected units
- 16,656
Distribution
Distributed nationwide across the United States.
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