FDA recall Z-2537-2018

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.

Reason for recall

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

Key facts

Status

Terminated

Initiation date

2017-09-05

Report date

2018-08-01

Termination date

2020-04-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Machesney Park, IL, United States

Primary source

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