Agfa N.V.: Medical Device Recall in 2019 - (Recall #: Z-2056-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications.

Product Classification:

Class II

Date Initiated: June 27, 2019

Date Posted: August 7, 2019

Recall Number: Z-2056-2019

Event ID: 83400

Reason for Recall:

The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.

Status: Terminated

Product Quantity: 4

Code Information:

Model/Serial Number/s: 00925, 00945, and 00949, 1136

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

FDA Mandated