Date Initiated by Firm | September 05, 2017 |
Create Date | July 25, 2018 |
Recall Status1 |
Terminated 3 on April 13, 2020 |
Recall Number | Z-2537-2018 |
Recall Event ID |
80510 |
510(K)Number | K122413 |
Product Classification |
Couch, radiation therapy, powered - Product Code JAI
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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. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Forte Automation Systems Inc 8155 Burden Rd Machesney Park IL 61115-8208
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For Additional Information Contact | Phil Reece 815-633-2300 |
Manufacturer 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 2 | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JAI
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