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U.S. Department of Health and Human Services

Class 2 Device Recall DR 800 with MUSICA Dynamic

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  Class 2 Device Recall DR 800 with MUSICA Dynamic see related information
Date Initiated by Firm April 06, 2020
Create Date June 03, 2020
Recall Status1 Terminated 3 on April 03, 2023
Recall Number Z-2202-2020
Recall Event ID 85599
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, 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
Code Information Serial Numbers: 0925, 0945, 0948, 0949, 1003, 1022, 1116, 1136, 1161, 1229, 1239, 1401, and 1404
Recalling Firm/
Manufacturer		 Agfa N.V.
Septestraat 27
Mortsel Belgium
Manufacturer 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 2		 Software design
Action 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.
Quantity in Commerce 13 units
Distribution US Nationwide distribution including in the sates of FL, IL, IN, LA, MA, MO, OH, SC, VA, WI.
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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