Recall – Forte Automation Patient Positioning System Cl II

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

___________________________________

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

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