Company: Forte Automation Systems Inc.
Date of Enforcement Report: 8/1/2018
Class II:

PRODUCT
Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.

Recall Number: Z-2537-2018

REASON
Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.

RECALLING FIRM/MANUFACTURER
Forte Automation Systems Inc., Machesney Park, IL on 9/5/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
13

DISTRIBUTION
California