Hologic Selenia Full Field Digital Mammography System:… recallZ-1700-2014 · Hologic, Inc. · initiated May 13, 2014
Class II Terminated All recalls posted in June 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Component change control
What the company is doing
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.
Recall details
- Recall number
- Z-1700-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 13, 2014
- Posted by the FDA
- Jun 3, 2014
- Recalling firm
- Hologic, Inc.
- Quantity
- 11 units
- Product code
- MUE
- FDA submissions
- P010025
- Distribution
- Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
Product description
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.
Code information (models, lots, serial numbers)
Serial Numbers: 2840314W8065, 2840314W8062W, 2840314W8066W, 2840314W8067 2840314W8073, 2840314W8064, 2840314W8056W, 28401082720 28407083579, 28401137611W, 28403083045W
Other devices under the same FDA submission
5 devices cleared under P010025 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Selenia Dimensions ASY-04160Hologic, Inc. · Full field digital,system,x-ray,mammographic2 recalls47 reports
- Selenia Dimensions ASY-01966Hologic, Inc. · Full field digital,system,x-ray,mammographic131 reports
- Selenia Dimensions ASY-07460Hologic, Inc. · Full field digital,system,x-ray,mammographic6 reports
- Selenia Dimensions ASY-08483Hologic, Inc. · Full field digital,system,x-ray,mammographic5 reports
- Selenia FFDM ASY-00676Hologic, Inc. · Full field digital,system,x-ray,mammographic5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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