FDAClass IIOctober 2, 2019

Proteus XR/a recall

Proteus XR/a (SlOK : K993090)

Why was Proteus XR/a recalled?

Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)

Product
Proteus XR/a (SlOK : K993090)
Recalling firm
GE Healthcare, LLC
Quantity
647 US; 167 OUS
Distribution
Worldwide - US Nationwide
Recall date
October 2, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls