Z-1034-2019Class III

PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ

Name: Z-1034-2019 PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ
Creator: Agfa N.V.
Published: 2019-01-25
License: https://open.fda.gov/license/

Agfa N.V. / initiated 2019-01-25 / Terminated

FDA source

Agfa N.V. began a recall of PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution... on 2019-01-25. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1034-2019
Classification: Class III
Status: Terminated
Initiated: 2019-01-25
Posted: 2019-03-21
Terminated: 2019-06-14
Recalling firm: Agfa N.V.
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.
Product code: IWZ Film, Radiographic
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 root cause: 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.
Product codes and lots: REF CODE/ BATCH XJUB8 36930048; XJM73 36930048; XJUDD 36930047; XJUDD 36940001; XJM85 36940001; XJUDD 36940002; EKLYZ 36940003.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1034-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1034-2019	Class III	Terminated	Voluntary: Firm initiated	2019-03-27	2019-03-21

Product code IWZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)