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MAVIG Clarification to the Safety Notice from Bayer
– Medical Device Field Corrective Action

On December 20, 2018, Bayer issued a safety notice regarding the OCS, EOC, EOW,
and EOA ceiling-mounted systems in the form of a client letter.

The letter mentions a possible loosening or disengagement of the injector head,
and explains that it pertains only to MAVIG Portegra (Hänel) and Portegra2 OCS
systems in conjunction with MEDRAD injectors.

 

We assure all MAVIG customers:

This safety notice was based on an insufficient description in the Bayer Installation
Instructions
(description see PDF below).

In no way, does this affect the product quality or safety of the Portegra2 system.
All MAVIG Portegra2 products are completely reliable and safe.

Please notice!

If you still have a old MAVIG Hänel system (Portegra OCS) in operation,
the lifespan of 10 years is already exceeded. In that case we recommend
urgently an exchange of the whole system to a Portegra2 system.

 

The complete MAVIG clarification can be found here:

MAVIG Clarification to Bayer Safety Notice.pdf

For any questions please contact us. info@mavig.com

Copyright © 2019 MAVIG GmbH. All rights reserved.
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