Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM
This recall has been terminated (originally issued December 16, 2014).
- Company
- Agfa Healthcare Corp.
- Recall Initiated
- October 24, 2014
- Posted
- December 16, 2014
- Terminated
- March 16, 2015
- Recall Number
- Z-0804-2015
- Quantity
- 142 units
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
Reason for Recall
Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.
Distribution
US Nationwide Distribution in the states of: AL, AZ, CA, LA, MI, NE, NH, NJ, NC, VA
Lot / Code Info
Lot 79440009
Root Cause
Other
Action Taken
Dealers were contacted by Agfa HealthCare via phone and/or email on 10/24/2014 and the week of 11/10/14 to inform them of the quality issue and to quarantine identified product shipped to their facility or end users. On 11/17/2014, an "URGENT SAFETY NOTICE" letter was sent to the US dealers. 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 they could sent it to the end use customers.