Recall Z-2537-2018 ยท JAI Couch, Radiation Therapy, Powered
Forte Automation Systems Inc
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.
| Date | Sep 5, 2017 |
| Status | Terminated |
| Reason | Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator. |
| 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 perm |
| Quantity | 13 |
| Distribution | US in the state of California |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122413 | PATIENT POSITIONING SYSTEM Forte Automation Systems, Inc., Sep 13, 2012 |