Z-2537-2018 Class II Terminated
FDA device recall Z-2537-2018 was initiated by Forte Automation Systems Inc on September 5, 2017 and is designated Class II. Reason for recall: Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator. The recall status is terminated (terminated April 13, 2020). Affected quantity: 13.
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2018
- Initiation Date
- September 5, 2017
- Termination Date
- April 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13
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.
Reason for Recall
Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.
Distribution Pattern
US in the state of California
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