ATC NEWS

No. 016

Stop of sales activities concerning neuro-surgery application

Metzingen, 3.04.2012

Dear Ladies and Gentlemen,

As safety officers we need to inform you about a temporary stop for sales, marketing and offers
to neuro-surgery.

Due to change of European regulations the risk classification of several intra-operative Hitachi-
Aloka probes has changed.
All intra-operative probes which are used with direct contact to the central nervous system
(including brain, spine, etc.) have to be classified as Class III devices. The current classification is
Class IIa.

Hitachi-Aloka in Japan is currently investigating further actions with the Notified Body.
All further required actions, which apply to already sold probes for neuro-surgical purposes will
be informed soon.

As discussed with the European management of Hitachi Medical Systems, we request you to
stop any offer, advertisement, marketing and sales for any neuro-surgical purpose. This in-
cludes handing out brochures.

This stop will be effective from now until further notice.

For further questions please contact the respective safety officer as written below.

Sincerely yours,

Arne Buschhausen Holger Scholl

Regulatory Affairs Specialist, Safety Officer Manager Regulatory Affairs, Safety Officer
Aloka Europe Technical Center Hitachi Medical Systems GmbH
a.buschhausen@hitachi-medical-systems.com h.scholl@hitachi-medical-systems.com

ALOKA EUROPE Technical Center

Carl-Zeiss-Strasse 5, D-72555 Metzingen Tel: +49 7123 9605 0 Fax: +49 7123 9605 388
Eine Zweigniederlassung der Hitachi Medical Systems Europe Holding AG, Sumpfstrasse 13, CH-6300 Zug, Schweiz
www.hitachi-medical-systems.eu