Company:AGFA Copr.
Date of Enforcement Report 7/6/2011
Class ll:
PRODUCT
NX is the radiographer’s image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed quickly and effortlessly with a simple touch screen. In-room integration provides a more convenient workflow for the radiographer throughout the imaging process. NX communicates seamlessly with the hospital’s picture archiving and communication system (PACS), radiology information system (RIS) and hospital information system (HIS). It is DICOM compliant and meets IHE guidelines. Recall # Z-2137-2011
REASON
When a radiographer is working on two open studies on an NX workstation and, in specific situations, a problem of image/annotation mix-up can occur on the NX system.
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter on March 4, 2011.
Manufacturer: Agfa Gevaert Healthcare Gmbh, Peissenberg, Germany. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
775 units
DISTRIBUTION
Nationwide and Canada
