Recall Z-2202-2020
Agfa N.V. · initiated April 6, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Serial Numbers: 0925, 0945, 0948, 0949, 1003, 1022, 1116, 1136, 1161, 1229, 1239, 1401, and 1404
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
FDA-determined cause: Software design
Action taken
Agfa issued Urgent Field Safety Notice via email on 4/21/20 to consignees, letter states reason for recall, health risk and action to take: Acknowledgment, via a feedback form or email, that the information was received and understood was requested from the consignees.
Details
- Recall number
- Z-2202-2020
- Initiated
- April 6, 2020
- Terminated
- April 3, 2023
- Product code
- JAA – System, X-Ray, Fluoroscopic, Image-Intensified
- Quantity
- 13 units
- Distribution
- US Nationwide distribution including in the sates of FL, IL, IN, LA, MA, MO, OH, SC, VA, WI.
- Recalling firm
- Agfa N.V., Mortsel