FDA recall Z-2202-2020

Agfa N.V. · Class II · device

Product

AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following 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

Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible

Distribution

US Nationwide distribution including in the sates of FL, IL, IN, LA, MA, MO, OH, SC, VA, WI.

Key facts

Status
Terminated
Initiation date
2020-04-06
Report date
2020-06-10
Termination date
2023-04-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mortsel, N/A, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2202-2020