FDAClass IIJuly 22, 2015

IMPAX Agility. IMPAX Agility when deployed as a recall

IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the…

Why was IMPAX Agility. IMPAX Agility when deployed as a recalled?

Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Agility side the patient name was incorrect.

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?

N/A

Product
IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the…
Recalling firm
AGFA Healthcare Corp.
Quantity
2
Distribution
Distributed in the state of MO.
Recall date
July 22, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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