Reported Aug 1, 2018 · Terminated

Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient…

Forte Automation Systems Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Forte Automation Systems Inc · 8155 Burden Rd · Machesney Park, IL · 61115-8208

Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10
Product UsageThe 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

Lot codes and dates: 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
Amount recalled: 13

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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