Recall Z-1546-2008 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Lorad, A Hologic, Inc.
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
| Date | May 28, 2008 (initiated Feb 28, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 73 units |
| Distribution | Worldwide Distribution including USA and countries of Canada and the Republic of Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.