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U.S. Department of Health and Human Services

Class 2 Device Recall PATIENT POSITIONING SYSTEM

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  Class 2 Device Recall PATIENT POSITIONING SYSTEM see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = JAI and Original Applicant = FORTE AUTOMATION SYSTEMS, INC.
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