Z-2137-2011

NX is the radiographer's image identification and quality control tool. It offers a broad array of features...

Name: Z-2137-2011 NX is the radiographer's image identification and quality control tool. It offers a broad array of features...
Creator: AGFA Corp.
Published: 2011-03-04
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2011-03-04 / Terminated

FDA source

AGFA Corp. began a recall of 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... on 2011-03-04. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2137-2011
Status: Terminated
Initiated: 2011-03-04
Posted: 2011-05-04
Terminated: 2012-03-27
Recalling firm: AGFA Healthcare Corp.
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.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 775 units
Distribution: Worldwide Distribution - USA including CA, GA, MS, ND, NM, NY, OK, PA, SC, SD, TX, and VA and the country of Canada
Product codes and lots: 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

Product code MQB

K071162Class IIAgfa Computed Radiography System with Nx2.x WorkstationsAgfa Healthcare Corp. / cleared 2007-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)