Recall Z-1034-2019— Agfa N.V.
Class III · Terminated
Class III FDA medical device recall by Agfa N.V., initiated 2019-01-25, terminated 2019-06-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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.
- Recalling firm
- Agfa N.V.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-01-25
- Terminated
- 2019-06-14
- Firm location
- Mortsel, N/A, Belgium
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.