Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8

FDA device recall Z-2178-2014 · posted 2014-08-10 · Terminated

Recall details

Recalling firm

AGFA Healthcare Corp.

Reason for recall

Some sheets of the medical screen film are fogged.

Action taken

On July 16, 2014, an "URGENT FIELD SAFETY NOTICE" letter was sent to the US and Canadian dealers (consignees). 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 that it could be sent to their customers.

Root cause

Process design

Status

Terminated

Product code

IWZ

Quantity affected

2617

Distribution

Worldwide Distribution and US Nationwide in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC and country of Canada

Date initiated

2014-07-16

Date posted

2014-08-10

Date terminated

2014-12-09

Location

Greenville, SC