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.
- Company
- Agfa Corp.
- Recall Initiated
- October 4, 2011
- Posted
- November 25, 2011
- Terminated
- December 22, 2011
- Recall Number
- Z-0285-2012
- Quantity
- 125
- Firm Location
- Greenville, SC
Reason for Recall
The film notch was located in the wrong position.
Distribution
Worldwide Distribution -- USA, including the states of IN, KS, MI, MN, MO, NC, NE, NY, OH, and TN and the country of Canada.
Lot / Code Info
79890049
Root Cause
Process control
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.