Dear distributor,
M19-01 Nota informativa
rev.1.06 del 30/08/2016
attached to this letter you’ll find an IMPORTANT SAFETY NOTICE regarding Micromed systems installed on
a CAR POLE cart.
Some of these systems or cart have been provided to the users through your company (see list in Annex 2).
We kindly ask you to inform all customers to which you provided the affected devices , by providing them the
attached document FSN18001, within 15 February 2018:
Formal confirmation must be provided to Micromed by filling and returning the specific form (annex 1) within
Friday 16 February 2018.
This Field safety Notice has been notified to the Competent Authority of your country (Ministry of health or
Medical Device agency) .
We’ll then ask you cooperation for proceed with the corrective actions described in the Field Safety Notice.
We thank you in advance for the cooperation .
For any information or clarification, please contact directly our Quality and Regulatory office (Ms. Monica
, +39-041-5937000).
Best regards
Annexes
…
…
Micromed S.p.A.
- Annex 1 – Receipt Form to be returned filled and signed to
within 16 February 2018
- Annex 2 – List of affected devices supplied to your company
- Field safety Notice FSN18001 document for the system users (7 pages)
