Recall Z-1726-2009
Hologic, Inc. · initiated April 7, 2009
Product
Hologic Explorer 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: 90877 90968 91005 91165 91206 90139 90941 90944 91327 90865 90936 90952 91032 91126 91127 91193 91228 90921 91022 91308 91328 90859 90860 90899 90885 90969 90970 91057 91070 91107 91141 91222 91296 91434 91065 90843 90846 90929 90930 90931 90932 90933 90935 90948 90950 90951 90961 90962 90963 90964 90965 91013 91014 91015 91016 91017 91018 91019 91020 91043 91044 91045 91046 91047 91048 91049 91050 91151 91152 91153 91154 91155 91213 91214 91215 91218 91238 91239 91240 91241 91242 91243 91253 91254 91256 91257 91262 91263 91265 91266 91268 91269 91310 91311 91312 91313 91314 91315 91351 91352 91355 91356 91357 91358 91359 91360 91382 91383 91384 91385 91386 91387 91426 91129 90849 90867 91051 90889 91012 91039 91054 91099 91100 91143 91345 91361 91411 91457 91459 91076 91258 90866 90875 90879 90916 90917 90918 90945 90939 90942 90953 90971 90972 90976 90995 90996 91009 91033 91036 91059 91060 91068 91069 91071 91072 91105 91106 91111 91118 91123 91124 91133 91137 91138 91181 91182 91202 91211 91221 91223 91225 91259 91283 91284 91285 91287 91299 91300 91301 91316 91317 91322 91324 91331 91337 91350 91367 91368 91370 91409 91415 91416 91420 91437 91438 91444 91429 90912 90913…
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-1726-2009
- 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-1725-2009 | Hologic Discovery 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 |