Recall Z-0449-2009 ยท KGI Densitometer, Bone
Hologic, Inc.
Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software
| Date | Dec 29, 2008 (initiated Sep 24, 2008) |
| Status | Terminated |
| Reason | Software error may lead to a high estimate of major fracture probability. |
| Root cause | Software design |
| Action | Hologic notified customers by telephone on 9/23 and 24/08 and instructed them to not use the software. A customer notification letter was sent via FedEx to customers on September 25, 2008.The letter requested de-installation of the software and return of the software to Hologic in a pre-paid envelope. |
| Quantity | 15 software discs |
| Distribution | Nationwide distribution in: CO, MA, MN, NM, NY, NC, OR, OH, PA, and TX. Also distributed in the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080711 | 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION Hologic, Inc., Sep 2, 2008 |