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.
Recall
- Recall Number
- Z-0285-2012
- Event Number
- 60166
- Firm
- AGFA Corp.
- FEI Number
- 3001236302
- Product Code
- IWZ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- October 4, 2011
- Posted
- November 25, 2011
- Terminated
- December 22, 2011
- Address
- 10 S Academy St, Greenville, SC, 29601-2632
Description
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.
The film notch was located in the wrong position.
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.
Worldwide Distribution -- USA, including the states of IN, KS, MI, MN, MO, NC, NE, NY, OH, and TN and the country of Canada.
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