Z-2537-2018 Class II Terminated

Recalled by Forte Automation Systems Inc — Machesney Park, IL

Recall Details

Product Type
Devices
Report Date
August 1, 2018
Initiation Date
September 5, 2017
Termination Date
April 13, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13

Product Description

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.

Reason for Recall

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

Distribution Pattern

US in the state of California

Code Information

PPS Serial Number Cabinet Type Software Version 7757-11 KRC2 2.3.3 7757-21 KRC2 2.3.3 7757-31 KRC2 2.3.3 7757-41 KRC2 2.3.3 7757-51 KRC2 2.3.8 7755-21 KRC2 2.3.3 7755-31 KRC2 2.3.3 7755-41 KRC2 2.3.3 7392-2 KRC2 2.3.3 7392-3 KRC2 2.3.3 7392-4 KRC2 2.3.3 7392-1 KRC2 2.3.8 7392-5 KRC2 2.3.8