Forte Automation Systems, Inc.

Machesney Park, IL, US

Forte Automation Systems, Inc. appears in FDA device records in Machesney Park, IL. FDA records list 2 510(k) clearances between 2012-09-13 and 2017-04-13, no PMA records and no registered establishments. As of 2026-09-10, FDA records show one recall for this company.

510(k) clearances: 2
PMA records: 0
Recall records: 1
Registered establishments: 0

510(k) clearance history

FDA records hold 2 510(k) clearances for Forte Automation Systems, Inc. between 2012 and 2017. The busiest year on record is 2012, with 1. The most recent is 2017, with 1.

Clearances by year, as a table

510(k) clearance decisions for Forte Automation Systems, Inc., by decision year
Year	Clearances
2012	1
2017	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K170502	Patient Positioning System	JAI	Substantially Equivalent	2017-04-13
K122413	PATIENT POSITIONING SYSTEM	JAI	Substantially Equivalent	2012-09-13

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

JAICouch, Radiation Therapy, Powered

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2537-2018	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.	Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.	Class II	2017-09-05	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain