Recall Z-2187-2008
Hologic, Inc. · initiated June 27, 2008
Product
Hologic Explorer Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given 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: 91108 90941 91022 90952 91032 91127 91126 91193 91065 90885 91222 91070 91141 91057 90970 90969 91107 91050 91013 91014 91015 91016 91017 91018 91019 91020 91043 91044 91045 91046 91047 91048 91049 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 91051 91099 91165 91100 91143 91054 91012 91039 91076 91258 91224 91260 91261 90920 90924 90934 90938 90923 91028 91029 91031 91026 91030 91113 91114 91128 91180 91186 91187 91183 91210 91212 91226 91208 91227 91229 91252 91034 91205 91281 91111 91211 91202 91228 90939 90945 90953 90971 90972 90942 90976 90995 90996 91009 91033 91036 91060 91071 91072 91068 91069 91059 91105 91106 91118 91123 91124 91133 91137 91138 91181 91182 91221 91223 91225 91259 91283 90911 90978 90994 91066 91103 91104 91125 91250 91064 91075 90988 91174 91271 91109 91110 91132 91135 91184 91094 90954 90955 90956 90957 90958 91097 91098 91101 91102 91136 91146 91147 91148 91149 91150 90977 90984 90985 90986 90987 90997 90998 90999 91001 91002 91003 91007 91008 91052 91053 91055 91077 91078 91079 91080 91085 91086 91087 91157 91158 91159 91198 91199 91168 91169…
Reason for recall
Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
FDA-determined cause: Software design
Action taken
Hologic notified customers by registered letter titled Urgent: Medical Device Recall, dated 6/27/08, providing instructions to update the software to Version 2.3 and discard version APEX 2.0, 2.1 and 2.2 manuals. If you have questions or require assistance with the software installation, contact Hologic's Help Desk at 1-800-321-4659.
Details
- Recall number
- Z-2187-2008
- Initiated
- June 27, 2008
- Posted by FDA
- September 17, 2008
- Terminated
- October 25, 2010
- Product code
- KGI – Densitometer, Bone
- Quantity
- 325 units
- Distribution
- Nationwide Foreign: Canada Algeria, AE, Australia, Belgium,China,France, Germany, Hungary, Hong Kong, Iceland, Iran, Ireland, Israel, Italy,Japan,Korea, Kuwait, Lithuania, Mexico, Myanmar, Netherlands, Pakistan, Peru, Russia, S. Africa, Saudi Arabia, Singapore, Slovak Rep., Switzerland, Syria, Taiwan, UK
- Recalling firm
- Hologic, Inc., Bedford, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2184-2008 | Hologic Discovery Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is…Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 06/27/2008Terminated |
| Z-2185-2008 | Hologic QDR4500 Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is…Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 06/27/2008Terminated |
| Z-2186-2008 | Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is…Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 06/27/2008Terminated |
| Z-2188-1991 | Hologic Oasis Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is…Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 06/27/2008Terminated |