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
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