Z-1062-2012

Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are...

Name: Z-1062-2012 Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are...
Creator: AGFA Corp.
Published: 2012-01-16
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2012-01-16 / Terminated / root cause: design

FDA source

AGFA Corp. began a recall of Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the... on 2012-01-16. The reason FDA records is "The firm received a complaint that when using the DX-D Mobile DR X-Ray unit they noticed the detector cable was hot". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1062-2012
Status: Terminated
Initiated: 2012-01-16
Posted: 2012-02-19
Terminated: 2012-05-10
Recalling firm: AGFA Healthcare Corp.
Product: Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the DX-D systems) Product Usage: DX-D Imaging Package ha the same intended use as the predicative devices: namely to provide diagnostic quality images to aid the physician with diagnosis. The device uses Agfas fla panel detectors with amorphous silicon scintillators and NX workstations with MUSICA imaeg processing to create radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The product is not indicated for use in mammography.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: The firm received a complaint that when using the DX-D Mobile DR X-Ray unit they noticed the detector cable was hot.
Root cause tag: design
FDA root cause: Device Design
Action: AGFA Corp. sent an "URGENT FIELD SAFETY NOTICE" letter dated January 16, 2012 to affected consignees. The letter described the affected product, concerns, issues and actions to be taken. Customers have been requested to place the Varian warning label included in a highly visible and suitable position on the cable of the portable detector. Customers were instructed to complete and return the feedback form by fax to 864-421-1664, as soon as possible. For questions about this matter contact your local AGFA HealthCare Technical Support at 877-777-2432.
Quantity in commerce: 42 units
Distribution: Nationwide Distribution (USA) including the states of: FL, IL, IN, KS, MI, MN, MS, NE,NY, OH, SC and WV.
Product codes and lots: Model Numbers DX-D 20G and DX-D 20C; Catalog Numbers ABC Code 5PYTM and 5PYUO

Product code MQB

K092669Class IIDx-D Imaging PackageAgfa Healthcare N.V. / cleared 2009-11-06

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)