FDA Medical Device Recalls (openFDA)
Lorad, A Division of Hologic: Lorad MIV Platinum Mammograpgy System
- Recall number
- Z-0149-04
- Recalling firm
- Lorad, A Division of Hologic
- Product
- Lorad MIV Platinum Mammograpgy System
- Status
- Terminated
- Initiated
- 2004-01-14
- Posted
- 2004-08-11
- Terminated
- 2004-09-15
- Reason
- System failed to meet the mA's accuracy specfications at low mA's values
- Root cause
- Other
- Action
- Lorad notified customers/dealers by letter dated January 14, 2004. Sites were advised of the corrected Accuracy labeling.
- Quantity
- not on file
- Distribution
- Nationwide
- Lot, serial or model codes
- S/N''s :18005960001 to 18010034196
- 510(k) numbers
- ["K011987"]
- PMA numbers
- not on file
- Product code
- IZH
- Firm FEI
- 1220984
- Firm city
- Danbury
- Firm state
- CT
- 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