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.
FDA Recall Z-1062-2012 · Posted 2012-02-19
Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeMQB
Date Initiated2012-01-16
Date Terminated2012-05-10
Product Quantity42 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution (USA) including the states of: FL, IL, IN, KS, MI, MN, MS, NE,NY, OH, SC and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.