Forte Automation Systems Inc recalls Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positio…

Recall date

September 5, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2537-2018

FDA classification

Class II

Brand / firm

Forte Automation Systems Inc

Sold / distributed

US in the state of California

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.