Z-0804-2015 Class III Terminated
FDA device recall Z-0804-2015 was initiated by AGFA Healthcare Corp. on Oct 24, 2014 and is designated Class III. Reason for recall: Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed. The recall status is terminated (terminated Mar 16, 2015). Affected quantity: 142 units.
Recall details
- Product Type
- Devices
- Report Date
- Dec 24, 2014
- Initiation Date
- Oct 24, 2014
- Termination Date
- Mar 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 142 units
Product description
Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM
Reason for recall
Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.
Distribution pattern
US Nationwide Distribution in the states of: AL, AZ, CA, LA, MI, NE, NH, NJ, NC, VA
Code information
Lot 79440009
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0804-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026