Recall Z-2537-2018— Forte Automation Systems Inc

Name: FDA recall Z-2537-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-05

Class II · Terminated

Class II FDA medical device recall by Forte Automation Systems Inc, initiated 2017-09-05, terminated 2020-04-13. It names one FDA 510(k) clearance: K122413. 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.. Reason: Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator..

Recalling firm: Forte Automation Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2017-09-05
Terminated: 2020-04-13
Firm location: Machesney Park, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K122413 — PATIENT POSITIONING SYSTEMForte Automation Systems, Inc.·cleared 2012-09-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.