FDA Medical Device Recalls (openFDA)
AGFA Corp.: Radiomat Lightweight Cassettes
- Recall number
- Z-1404-05
- Recalling firm
- AGFA Corp.
- Product
- Radiomat Lightweight Cassettes
- Status
- Terminated
- Initiated
- 2005-01-26
- Posted
- 2005-08-25
- Terminated
- 2006-06-20
- Reason
- Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images.
- Root cause
- Other
- Action
- Consignees were notified by letter on/about 07/29/2005.
- Quantity
- 9055 units
- Distribution
- Nationwide, Canada
- Lot, serial or model codes
- Product Code: EHYG2, Model: 14x17 Green RE 400 Screens and Cassettes, Product Code: EHYCT, Model: 14x17 Green RE 100 Screens and Cassettes, Product Code: EHX5C, Model: 14x17 Blue RE 800 Screens and Cassettes, Batch number are a combination of 4 letters/numbers xxyy, where xx varies alphabetically form 6N and 6Z and from 7A to &N and yy is a number from 01 through 31. Batch numbers are located both on the cassette shell and on the outer label.
- 510(k) numbers
- ["K023020"]
- PMA numbers
- not on file
- Product code
- IXA
- 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
- 2026-10-06
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