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U.S. Department of Health and Human Services

Class 2 Device Recall Agfa DR 800

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  Class 2 Device Recall Agfa DR 800 see related information
Date Initiated by Firm February 10, 2020
Create Date March 18, 2020
Recall Status1 Terminated 3 on March 30, 2023
Recall Number Z-1502-2020
Recall Event ID 85028
510(K)Number K183275  
Product Classification System, x-ray, tomographic - Product Code IZF
Product AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
Code Information Serial Numbers: 00949, 1161
Recalling Firm/
Manufacturer		 Agfa N.V.
Septestraat 27
Mortsel Belgium
Manufacturer Reason
for Recall		 Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
FDA Determined
Cause 2		 Under Investigation by firm
Action AFGA issued via email On February 10, 2020, an URGENT FIELD SAFETY NOTICE letter. Letter states reason for recall, health risk, and action to take: With this letter, Agfa is informing you that the DR 800 system still can be used including for Tomosynthesis for mAs values which are larger than 0,2 mAs. In case Tomosynthesis image acquisition sequence does not stop automatically after the expected number of exposures, release the exposure button as this will stop the sequence and notify your Agfa Service contact at once. Contact your local Agfa Imaging organization 1-877-777-2432 and please reference Problem Record PRB2000387 and Vigilance Record VR0000716. Complete/Return by fax or email the URGENT FIELD SAFETY NOTICE Feedback form
Quantity in Commerce 2 units
Distribution US Nationwide distribution in the states of FL, VA.
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 = IZF and Original Applicant = Agfa N.V.
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