PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 22, 2015 Initiated: June 26, 2015 #Z-2061-2015

Product Description

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.

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.

Details

Recalling Firm
AGFA Healthcare Corp.
Units Affected
2
Distribution
Distributed in the state of MO.
Location
Greenville, SC

Frequently Asked Questions

What product was recalled?
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.. Recalled by AGFA Healthcare Corp.. Units affected: 2.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 22, 2015. Severity: Moderate. Recall number: Z-2061-2015.