Recall Z-2056-2019— Agfa N.V.
Class II · Terminated
Class II FDA medical device recall by Agfa N.V., initiated 2019-06-27, terminated 2020-06-03. It names one FDA 510(k) clearance: K180589. Product: 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: The exposed area of fluo exams possibly does not match the active area of the detector within specified limits..
- Recalling firm
- Agfa N.V.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-27
- Terminated
- 2020-06-03
- Firm location
- Mortsel, N/A, Belgium
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.