Z-2061-2015 Class II Terminated

Recalled by AGFA Healthcare Corp. — Greenville, SC

Recall Details

Product Type
Devices
Report Date
July 22, 2015
Initiation Date
June 26, 2015
Termination Date
January 27, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

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.

Distribution Pattern

Distributed in the state of MO.

Code Information

N/A