Z-2056-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2019
- Initiation Date
- June 27, 2019
- Termination Date
- June 3, 2020
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 4
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.
Reason for Recall
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
Distribution Pattern
US Nationwide Distribution
Code Information
Model/Serial Number/s: 00925, 00945, and 00949, 1136