FDAClass IIMarch 6, 2013

GE Healthcare Definium 5000/5220493-2 X-Ray System recall

GE Healthcare Definium 5000/5220493-2 X-Ray System

Why was GE Healthcare Definium 5000/5220493-2 X-Ray System recalled?

When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.

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?

Definium Model 5000/5220493-2

Product
GE Healthcare Definium 5000/5220493-2 X-Ray System
Recalling firm
GE Healthcare, LLC
Quantity
312 installed in US
Distribution
Nationwide Distribution
Recall date
March 6, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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