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

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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

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Partners located in the US (CA, FL, MA, MN) and Italy.