Machesney Park, IL, United States
Forte Automation Systems Inc recalls
1 recall recorded since 2018, most recently on 5 September 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 5 September 2017
- Terminated
- 13 April 2020
- Reason
- Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.
- Distribution
- US in the state of California
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2537-2018
- 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 procedur
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.