FDAClass IIOctober 30, 2013

IMPAX 5.2 DB Server recall: Software Issue

IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).

Why was IMPAX 5.2 DB Server recalled?

System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.

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 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
Recalling firm
AGFA Corp.
Quantity
4
Distribution
Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.
Recall date
October 30, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls