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
FDA device recall Z-0804-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- AGFA Healthcare Corp.
- Reason for recall
- Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IWZ
- Quantity affected
- 142 units
- Distribution
- US Nationwide Distribution in the states of: AL, AZ, CA, LA, MI, NE, NH, NJ, NC, VA
- Date initiated
- 2014-10-24
- Date posted
- 2014-12-16
- Date terminated
- 2015-03-16
- Location
- Greenville, SC
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