Selenia Full Field Digital Mammography System with Software… recallZ-1546-2008 · Lorad, A Hologic, Inc. · initiated Feb 28, 2008
Terminated All recalls posted in May 2008
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 Lorad, A 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
Marker Misalignment: The new software version contained a magnification factor that shows CAD markers misaligned with the identified indications. The marked area is misaligned up to 2cm from the indication.
FDA root cause category: Software design
What the company is doing
Consignees were notified by an Urgent Recall Notice sent on 3/21/08. The letter informed users that representatives were dispatched to all locations and they have corrected the magnification factor problem. The letter instructed users to re-evaluate any cases read using CAD from the period of installation until the date of system correction. The letter also instructed users that only images read with CAD markers are affected. The letter requests users to return a confirmation of notification. For additional information, contact 1-877-371-4372.
Recall details
- Recall number
- Z-1546-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 28, 2008
- Posted by the FDA
- May 28, 2008
- Recalling firm
- Lorad, A Hologic, Inc.
- Quantity
- 73 units
- Product code
- MUE
- FDA submissions
- P010025
- Distribution
- Worldwide Distribution including USA and countries of Canada and the Republic of Korea.
Product description
Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number: SEL-00002; Hologic, Danbury CT 06810
Code information (models, lots, serial numbers)
Serial Numbers: 28401060607, 28401060617, 28401060619, 28401060641, 28401060645, 28401071345, 28401071361, 28401071363, 28401082760, 28402050317, 28402071431, 28403060709, 28403071548, 28403071601, 28404060755, 28405060792, 28405060813, 28405071807, 28405071813, 28406071833, 28407050431, 28407060899, 28407071951, 28407072014, 28408050465, 28408072100, 28408072106, 28408072130, 28409030075, 28409030076, 28409050497, 28410072360, 28411061182, 28411061271, 28411072479, 28412050577, 28412050589, 28412061309, 28412061319, 28412061333, 28412061336, 28412061339, 28412072602, 29408072073, 28407072007S, 28409030072RF and 28409030077RM.
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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