Z-0285-2012

Curix Opthos H, size 35x43 cm A radiographic medical x-ray film designed to optimize diagnostic chest imaging...

Name: Z-0285-2012 Curix Opthos H, size 35x43 cm A radiographic medical x-ray film designed to optimize diagnostic chest imaging...
Creator: AGFA Corp.
Published: 2011-10-04
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2011-10-04 / Terminated / root cause: manufacturing process

FDA source

AGFA Corp. began a recall of Curix Opthos H, size 35x43 cm A radiographic medical x-ray film designed to optimize diagnostic chest imaging by providing complete diagnostic information... on 2011-10-04. The reason FDA records is "The film notch was located in the wrong position". 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-0285-2012
Status: Terminated
Initiated: 2011-10-04
Posted: 2011-11-25
Terminated: 2011-12-22
Recalling firm: AGFA Healthcare Corp.
Product: Curix Opthos H, size 35x43 cm A radiographic medical x-ray film designed to optimize diagnostic chest imaging by providing complete diagnostic information including superbly visualized lung detail along with a high level of retro-cardiac, sub-diaphragmatic and mediastinal information.
Product code: IWZ Film, Radiographic
Reason for recall: The film notch was located in the wrong position.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An "URGENT SAFETY NOTICE" letter was sent via email to the dealers on October 7, 2011. The letter describes the problem and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood has been requested from the dealer sites. Included in each dealer letter, Agfa also provided a customer notification letter to be sent to their end-use customers. Agfa has requested dealers and end-use customers to file a complaint at 1-877-777-2432 for any identified product still in their inventories. Agfa will replace product and arrange for return shipment.
Quantity in commerce: 125
Distribution: Worldwide Distribution -- USA, including the states of IN, KS, MI, MN, MO, NC, NE, NY, OH, and TN and the country of Canada.
Product codes and lots: 79890049

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)