FDAClass IIAugust 1, 2018

Patient Positioning System with KRC2 controller using recall

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…

Why was Patient Positioning System with KRC2 controller using recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Forte Automation Systems Inc
Quantity
13
Distribution
US in the state of California
Recall date
August 1, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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