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

FDA device recall Z-0285-2012 · posted 2011-11-25 · Terminated

Recall details

Recalling firm

AGFA Corp.

Reason for recall

The film notch was located in the wrong position.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

IWZ

Quantity affected

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.

Date initiated

2011-10-04

Date posted

2011-11-25

Date terminated

2011-12-22

Location

Greenville, SC