Recall Z-1725-2009
Hologic, Inc. · initiated April 7, 2009
Product
Hologic Discovery series Bone Densitometer System 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.
Codes / lots: S/N: 80348 80652 81530 82238 82256 82386 82437 82620 82632 82708 82793 82794 82796 82798 82799 82806 82808 82810 82811 82812 82813 82814 82815 82818 82824 82825 82826 82827 82828 82832 82833 82834 82835 82836 82837 82838 82839 82840 82842 82843 82844 82845 82846 82847 82851 82853 82854 82855 82856 82857 82859 82860 82862 82865 82866 82867 82872 82875 82876 82877 82879 82880 82881 82883 82887 82889 82891 82892 82895 82896 82897 82898 82900 82901 82902 82903 82904 82906 82909 82910 82911 82912 82916 82917 82918 82920 82921 82922 82924 82926 82927 82928 82929 82932 82933 82935 82936 82939 82941 82944 82945 82947 82949 82950 82956 82957 82958 82959 82960 82963 82964 82967 82968 82969 82970 82972 82976 82977 82978 82979 82981 82982 82983 82986 82988 82989 82990 82991 82992 82993 82996 83000 83001 83002 83003 83004 83005 83007 83008 83009 83010 83011 83013 83014 83015 83017 83018 83019 83020 83021 83022 83023 83025 83027 83028 83029 83032 83034 83035 83038 83039 83040 83041 83043 83044 83045 83046 83047 83049 83050 83051 83055 83057 83059 83062 83064 83065 83072 83074 83075 83076 83077 83080 83081 83082 83083 83084 83085 83086 83087 83088 83090 83091 83092 83093 83094 83096 83098 83100…
Reason for recall
System may not turn off at the end of the x-ray and cause additional x-ray exposure
FDA-determined cause: Component design/selection
Action taken
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 with software versions other than 12.6, 2.3, or 2.4: Customers were asked to upgrade their QDR software, return their old QDR software disk, and complete and return to Hologic the enclosed Confirmation of Notification.
Details
- Recall number
- Z-1725-2009
- Initiated
- April 7, 2009
- Posted by FDA
- August 25, 2009
- Terminated
- November 29, 2010
- Product code
- KGI – Densitometer, Bone
- 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, Switzerland, Turkey, Ukraine, Uzbekistan, Algeria, Arab Emirates, Argentina, Australia, Bahrain…
- Recalling firm
- Hologic, Inc., Bedford, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1726-2009 | Hologic Explorer series Bone Densitometer System Software versions 12.6, 2.3., or 2.4.…System may not turn off at the end of the x-ray and cause additional x-ray exposure | 04/07/2009Terminated |
| Z-1727-2009 | Hologic QDR 4500 series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated…System may not turn off at the end of the x-ray and cause additional x-ray exposure | 04/07/2009Terminated |
| Z-1728-2009 | Hologic Delphi series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated…System may not turn off at the end of the x-ray and cause additional x-ray exposure | 04/07/2009Terminated |