Z-2537-2018Class II

Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10

Name: Z-2537-2018 Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10
Creator: Forte Automation Systems Inc
Published: 2017-09-05
License: https://open.fda.gov/license/

Forte Automation Systems, Inc. / initiated 2017-09-05 / Terminated / root cause: software

FDA source

Forte Automation Systems Inc began a recall of 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... on 2017-09-05. FDA classified it as Class II and gives the reason as "Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2537-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-05
Posted: 2018-07-25
Terminated: 2020-04-13
Recalling firm: Forte Automation Systems, Inc.
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.
Product code: JAI Couch, Radiation Therapy, Powered
Reason for recall: Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.
Root cause tag: software
FDA root cause: Software design
Action: On September 5, 2017 Forte has distributed an Urgent Medical Device Correction letter with the following information, Subject: Robotic Treatment Table Positioning Error Commercial Name of Affected Product: Patient Positioning System Affected Version(s) / Lot(s): KRC2 Controllers with software version 2.3.1 2.3.10 Reference / FSCA Identifier: 3003900998-2017-00001 Type of Action: Notification and Correction This letter provides users with a Description of the Problem, Details, Recommended User Action and Forte Automation Systems, Inc. Actions. This document also Pending resolution with a permanent solution, Forte Automation Systems, Inc. recommends reimaging the patient prior to treatment, especially after any table movement. This includes movement initiated by the image position verification system. It also advises users that a solution for the issue is in development.
Quantity in commerce: 13
Distribution: US in the state of California
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2537-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2537-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-24

Product code JAI

K122413Class IIPatient Positioning SystemForte Automation Systems, Inc. / cleared 2012-09-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)