PlainRecalls
FDA Devices Moderate Class II Terminated

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 projec

Reported: August 7, 2019 Initiated: June 27, 2019 #Z-2056-2019

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.

Details

Recalling Firm
Agfa N.V.
Units Affected
4
Distribution
US Nationwide Distribution
Location
Mortsel, N/A

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Agfa N.V.. Units affected: 4.
Why was this product recalled? ▼
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 7, 2019. Severity: Moderate. Recall number: Z-2056-2019.

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