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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX Agility

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  Class 2 Device Recall IMPAX Agility see related information
Date Initiated by Firm June 26, 2015
Date Posted July 13, 2015
Recall Status1 Terminated 3 on January 27, 2016
Recall Number Z-2061-2015
Recall Event ID 71606
Product Classification System, image processing, radiological - Product Code LLZ
Product IMPAX Agility.

IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.
Code Information N/A
Recalling Firm/
AGFA Healthcare Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Debbie Huff
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Action PRB0046372 was created to address the corrective actions related to this issue. On 6/26/2015, an email communication, as an effectiveness check was sent to the two customers. Acknowledgment, via email, that the communication was received was requested from the consignees.
Quantity in Commerce 2
Distribution Distributed in the state of MO.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.