FDA Medical Device Recalls (openFDA)
Hologic, Inc.: Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
- Recall number
- Z-1700-2014
- Recalling firm
- Hologic, Inc.
- Product
- Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
- Status
- Terminated
- Initiated
- 2014-05-13
- Posted
- 2014-06-03
- Terminated
- 2014-08-18
- Reason
- Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury
- Root cause
- Component change control
- Action
- Hologic notified customers by letter dated 5/13/14 via certified mail or Federal Express to inform customers of the problem and provide acknowledgement of the notification and confirmation that their systems have been corrected A Dealer notification dated 5/13/14 sent by certified mail or Federal Express to inform Dealers of the need to notify their customers of the problem and to correct the identified Selenia system using Hologic Technical Bulletin TB-00806. On 5/16/14 the firm expanded the recall to an additional units Mammography System M-IV (2 units) and Selenia Mammography Systems (4) by letter dated 5/14/14. If there are any questions regarding this field correction, please call Hologic Customer Support at 877 371-4372.
- Quantity
- 11 units
- Distribution
- Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
- Lot, serial or model codes
- Serial Numbers: 2840314W8065, 2840314W8062W, 2840314W8066W, 2840314W8067 2840314W8073, 2840314W8064, 2840314W8056W, 28401082720 28407083579, 28401137611W, 28403083045W
- 510(k) numbers
- not on file
- PMA numbers
- ["P010025"]
- Product code
- MUE
- 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