Z-0804-2015Class III

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

Name: Z-0804-2015 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
Creator: AGFA Healthcare Corp.
Published: 2014-10-24
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2014-10-24 / Terminated

FDA source

AGFA Healthcare Corp. began a recall of 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 on 2014-10-24. FDA classified it as Class III and gives the reason as "Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0804-2015
Classification: Class III
Status: Terminated
Initiated: 2014-10-24
Posted: 2014-12-16
Terminated: 2015-03-16
Recalling firm: AGFA Healthcare Corp.
Product: 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
Product code: IWZ Film, Radiographic
Reason for recall: Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.
FDA root cause: Other
Action: Dealers were contacted by Agfa HealthCare via phone and/or email on 10/24/2014 and the week of 11/10/14 to inform them of the quality issue and to quarantine identified product shipped to their facility or end users. On 11/17/2014, an "URGENT SAFETY NOTICE" letter was sent to the US dealers. The letter described the safety alert and the request to quarantine affected product. Acknowledgment via FAX-Back or email that the information was received and understood was requested from the dealers. A customer Urgent Field Safety Notice was also provided to those dealers who had shipped affected product to end users so they could sent it to the end use customers.
Quantity in commerce: 142 units
Distribution: US Nationwide Distribution in the states of: AL, AZ, CA, LA, MI, NE, NH, NJ, NC, VA
Product codes and lots: Lot 79440009

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0804-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0804-2015	Class III	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-15

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)