Agfa N.V.: Medical Device Recall in 2019 - (Recall #: Z-1034-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: January 25, 2019

Date Posted: March 27, 2019

Recall Number: Z-1034-2019

Event ID: 82123

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

Status: Terminated

Product Quantity: 2029 boxes

Code Information:

REF CODE/ BATCH XJUB8 36930048; XJM73 36930048; XJUDD 36930047; XJUDD 36940001; XJM85 36940001; XJUDD 36940002; EKLYZ 36940003.

Distribution Pattern:

US nationwide distribution in the state of OH.

Voluntary or Mandated:

Voluntary: Firm initiated