Z-2178-2014Class III

Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17...

Name: Z-2178-2014 Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17...
Creator: AGFA Healthcare Corp.
Published: 2014-07-16
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2014-07-16 / Terminated / root cause: manufacturing process

FDA source

AGFA Healthcare Corp. began a recall of Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2... on 2014-07-16. FDA classified it as Class III and gives the reason as "Some sheets of the medical screen film are fogged". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2178-2014
Classification: Class III
Status: Terminated
Initiated: 2014-07-16
Posted: 2014-08-10
Terminated: 2014-12-09
Recalling firm: AGFA Healthcare Corp.
Product: Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.
Product code: IWZ Film, Radiographic
Reason for recall: Some sheets of the medical screen film are fogged.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On July 16, 2014, an "URGENT FIELD SAFETY NOTICE" letter was sent to the US and Canadian dealers (consignees). 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 that it could be sent to their customers.
Quantity in commerce: 2617
Distribution: Worldwide Distribution and US Nationwide in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC and country of Canada
Product codes and lots: Lot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2178-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2178-2014	Class III	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-09

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)