FDA-Device2018-08-01Class II

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.

Forte Automation Systems Inc
Hazard

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

Sold states
US in the state of California
Affected count
13
Manufactured in
8155 Burden Rd, N/A, Machesney Park, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2537-2018

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