Z-2056-2019 Class II Terminated
FDA device recall Z-2056-2019 was initiated by Agfa N.V. on Jun 27, 2019 and is designated Class II. Reason for recall: The exposed area of fluo exams possibly does not match the active area of the detector within specified limits. The recall status is terminated (terminated Jun 3, 2020). Affected quantity: 4.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 7, 2019
- Initiation Date
- Jun 27, 2019
- Termination Date
- Jun 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