Device 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.
Z-2537-2018
Product summary
- Event
- Event 80510
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13
- Official record key
device-enforcement:Z-2537-2018
Official wording
Reason: Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.
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
Derived failure modes
-
Unknown
Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.