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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JAA
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