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FDA Medical Device Recalls (openFDA)

AGFA Corp.: Mamoray HDR-C PLUS Mammography film

Recall number
Z-0788-06
Recalling firm
AGFA Corp.
Product
Mamoray HDR-C PLUS Mammography film
Status
Terminated
Initiated
2006-02-16
Posted
2006-04-22
Terminated
2006-06-23
Reason
The film was incorrectly notched.
Root cause
Other
Action
Consignees were notified by letter on/about 02/16/2006.
Quantity
16523 units
Distribution
Nationwide
Lot, serial or model codes
Product Code: EMLOV, Batch 37300052
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
2026-10-06

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

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