FDAClass IIFebruary 12, 2014

Impax RIS Qdoc 5.8 recall

IMPAX RIS QDOC 5.8

Why was Impax RIS Qdoc 5.8 recalled?

Patient name displayed (printed) on the Patient Report was the wrong patient name.

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?

Software IMPAX RIS 58 and higher

Product
IMPAX RIS QDOC 5.8
Recalling firm
AGFA Corp.
Quantity
14
Distribution
CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada
Recall date
February 12, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls