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Recall Observatory FDA recall evidence

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

September 05, 2017

Class II

Product summary

Firm
Forte Automation Systems Inc
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

    reason.no_named_rule · v1.0.0

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