Z-1034-2019 Class III Terminated
FDA device recall Z-1034-2019 was initiated by Agfa N.V. on January 25, 2019 and is designated Class III. 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 a… The recall status is terminated (terminated June 14, 2019). Affected quantity: 2029 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2019
- Initiation Date
- January 25, 2019
- Termination Date
- June 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2029 boxes
Product Description
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.
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
Distribution Pattern
US nationwide distribution in the state of OH.
Code Information
REF CODE/ BATCH XJUB8 36930048; XJM73 36930048; XJUDD 36930047; XJUDD 36940001; XJM85 36940001; XJUDD 36940002; EKLYZ 36940003.