Forte Automation Systems Inc: Medical Device Recall in 2018 - (Recall #: Z-2537-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 5, 2017

Date Posted: August 1, 2018

Recall Number: Z-2537-2018

Event ID: 80510

Reason for Recall:

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

Status: Terminated

Product Quantity: 13

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

Distribution Pattern:

US in the state of California

Voluntary or Mandated:

Voluntary: Firm initiated