RecallDepth

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.

Company
Agfa Corp.
Recall Initiated
March 4, 2011
Posted
May 4, 2011
Terminated
March 27, 2012
Recall Number
Z-2137-2011
Quantity
775 units
Firm Location
Greenville, SC

Reason for Recall

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.

Distribution

Worldwide Distribution - USA including CA, GA, MS, ND, NM, NY, OK, PA, SC, SD, TX, and VA and the country of Canada

Lot / Code Info

Software Versions: 2.0.8100, 3.0.8100, 2.0.8200, 3.0.8200, 2.0.8300, 3.0.8300, 2.0.8400, 3.0.8400, 2.0.8500, and 3.0.8500

Root Cause

Other

Action Taken

AGFA Corp. sent an "URGENT FIEL SAFETY NOTICE" letter via FED-EX to the customers on March 4, 2011. The letter describes the safety alert and mitigation. Customers were instructed to complete and return the Urgent Field Safety Notice Feedback Form by fax to 864-421-1664. For questions regarding this recall call 864-421-1815.

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