Recall Z-1728-2009 ยท KGI Densitometer, Bone
Hologic, Inc.
Hologic Delphi series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
| Date | Aug 25, 2009 (initiated Apr 7, 2009) |
| Status | Terminated |
| Reason | System may not turn off at the end of the x-ray and cause additional x-ray exposure |
| Root cause | Component design/selection |
| Action | Hologic issued an Urgent: Medical Device Recall customer notification letter, dated April 17, 2009, by certified mail to inform customers of the problem. With the notification letter, customers will receive the following: -Software version Apex 12.6.2, 2.3.2, or 2.4.2 -Instructions to upgrade their systems with the provided software and to verify the new version on the system as a confirmation that the software was successfully loaded. -New Operator's Manual for installations where the operating characteristics of the system have changed due to the software upgrade. For Customers with systems |
| Quantity | 1914 units total |
| Distribution | Worldwide Distribution -- USA, Canada, Europe, Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Great Britain, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072847 | APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS Hologic, Inc., Mar 28, 2008 |