FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0804-2015
- Recalling firm
- AGFA Healthcare Corp.
- Product
- 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
- Status
- Terminated
- Initiated
- 2014-10-24
- Posted
- 2014-12-16
- Terminated
- 2015-03-16
- 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 product to end users so they could sent it to the end use customers.
- Quantity
- 142 units
- Distribution
- US Nationwide Distribution in the states of: AL, AZ, CA, LA, MI, NE, NH, NJ, NC, VA
- Lot, serial or model codes
- Lot 79440009
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IWZ
- Firm FEI
- 3001236302
- Firm city
- Greenville
- Firm state
- SC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28