Recall Z-2537-2018
Forte Automation Systems Inc · initiated September 5, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
Reason for recall
Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-2537-2018
- Initiated
- September 5, 2017
- Terminated
- April 13, 2020
- Product code
- JAI – Couch, Radiation Therapy, Powered
- Quantity
- 13
- Distribution
- US in the state of California
- Recalling firm
- Forte Automation Systems Inc, Machesney Park, IL