Recall Z-0804-2015 ยท IWZ Film, Radiographic
AGFA Healthcare Corp.
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
| Date | Dec 16, 2014 (initiated Oct 24, 2014) |
| Status | Terminated |
| Reason | Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed. |
| Root cause | Other |
| Action | 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 p |
| Quantity | 142 units |
| Distribution | US Nationwide Distribution in the states of: AL, AZ, CA, LA, MI, NE, NH, NJ, NC, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.