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Aesculap AG

Quality Management

Field Safety Corrective Action: Product Recall


Product: GN200, defined serial numbers
Product Designation: LEKTRAFUSE HF GENERATOR BIPOLAR

Chairman of Supervisory Board: Executive Board: Corporate Office: Tuttlingen Bank Account: Address:
Page 2 to the Ietter of December 61h, 2016

lf you should have any questions about this Field Safety Corrective Action (FSCA), please get in touch with
the following contact person:

Local contact data

Piease make sure that all users of the above-mentioned products in your organization and other persons
who need tobe informed have gained knowledge of this FSCA. ln the event that you have issued devices to
a third party, please forward a copy of this information Ietter to the contact person stated below. Piease
keep this information Ietter at least to such time asthismatter has been resolved. The German Federal
Institute for Drugs and Medical Devices has received a copy of this FSCA.

Piease fill out the feedbackform attached and send it back to the contact person stated therein.

We regret the inconvenience caused by the implementation of these actions and thank you for your under-
standing and cooperation.

Sincerely,

Aesculap AG
HOSPITAL ___________________________________________________________________

CITY ___________________________________________________________________

NAME ___________________________________________________________________

DEPARTMENT ___________________________________________________________________

PHONE NO. ___________________________________________________________________

_______________________________ ________________________________
SIGNATURE DATE

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