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U.S. Department of Health and Human Services

Class 2 Device Recall AGFA Digital Radiography X Ray system DR 800

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  Class 2 Device Recall AGFA Digital Radiography X Ray system DR 800 see related information
Date Initiated by Firm June 27, 2019
Create Date July 30, 2019
Recall Status1 Terminated 3 on June 03, 2020
Recall Number Z-2056-2019
Recall Event ID 83400
510(K)Number K180589  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
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.
Code Information Model/Serial Number/s: 00925, 00945, and 00949, 1136
Recalling Firm/
Manufacturer		 Agfa N.V.
Septestraat 27
Mortsel Belgium
Manufacturer Reason
for Recall		 The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
FDA Determined
Cause 2		 Device Design
Action The firm sent notification letter dated June 27, 2019 to affected customers. The letter identified the affected product problem and actions to be taken. For questions about this matter,contact your local Agfa Imaging organization 1-877-777-2432 and please reference Problem Record. PRB2000198.
Quantity in Commerce 4
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = Agfa HealthCare N.V.
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