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U.S. Department of Health and Human Services

Class 3 Device Recall Agfa N.V.

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  Class 3 Device Recall Agfa N.V. see related information
Date Initiated by Firm January 25, 2019
Create Date March 21, 2019
Recall Status1 Terminated 3 on June 14, 2019
Recall Number Z-1034-2019
Recall Event ID 82123
Product Classification Film, radiographic - Product Code IWZ
Product PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film
REF:
XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities.





Code Information REF CODE/ BATCH  XJUB8 36930048;  XJM73 36930048;  XJUDD 36930047; XJUDD 36940001;  XJM85 36940001;  XJUDD 36940002;  EKLYZ 36940003.
Recalling Firm/
Manufacturer		 Agfa N.V.
Septestraat 27
Mortsel Belgium
Manufacturer Reason
for Recall		 Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Agfa issued Medical Device Recall letter by email dated 1/28/19 stating the problem, action to be taken, health risk and to block the material to prevent distribution.
Quantity in Commerce 2029 boxes
Distribution US nationwide distribution in the state of OH.
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.
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