Recall – Patient Positioning System

Company: Forte Automation Systems Inc.
Date of Enforcement Report: 8/1/2018
Class II:

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.

Recall Number: Z-2537-2018

REASON
Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.

RECALLING FIRM/MANUFACTURER
Forte Automation Systems Inc., Machesney Park, IL on 9/5/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
13

DISTRIBUTION
California

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.