Recall Z-2185-2008
Hologic, Inc. · initiated June 27, 2008
Product
Hologic QDR4500 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: 47733C 48128 45692A 45757W 48009C/NCE 48321C/NCE 49477W 50033C 47265C 49113C/CE 49170W/CE 49244C/CE 48815C/NCE 47638C 45801A/CE 47068C 50099C/CE 47758C 48939C 47092C 71239 45100SL 47629C 45273SL 45690SL/CE 47104C 45546A/CE 45744A/CE 45762A/CE 45633A/CE 45442SL 49189C 48783C 48397C/NCE 47763C 45916 49820 49823 49824 47339C 45597SL/CE 45520A/CE 47712C 48157W/CE 47501C 45352SL 48242C/NCE 45853SL/CE 45837SL/CE 47679C 48781C/NCE 48579C 47443 48610C 49423W/CE 49792C/CE 45434SL/CE 49848 47197C 48781C/NCE 47159W 45264 48224 45264A 45759 45759SL/CE 49404C/CE 45708SL/CE 45935SL/CE 48220W/CE 48269C/NCE 47478NCE 49194 48953C/NCE 45479A/CE 45640A/CE 49179 49576C 45496A/CE 45158SL/CE 45537A/CE 45553SL/CE 48789 47034W 45860SL/CE 45197A 45573SL/CE 50051C/CE 47822 49034W/CE 47512C 45674SL 48280C/NCE 48204W/CE 47345C 47677C/CE 45486 48063C 45550SL/CE 48064C/NCE 45668A/CE 49349C/CE 49259C/CE 47564C 47641C 48240C/NCE 49386 45523A/CE 45941SL/CE 45782SL/CE 47061C 47105C 48106C/NCE 49351C/CE 45498A/CE 48384C/NCE 45811SL/CE 49286C/CE 45443SL/CE 48231C/NCE 45492SL/CE 49367C/CE 48858C/NCE 47703C 45688SL/CE 49270W/CE 47262C 47710C 48431C/NCE 49124C/CE 48004C 45620SL/CE 48221W/CE 48963C/NCE 45495SL/CE…
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-2185-2008
- Initiated
- June 27, 2008
- Posted by FDA
- September 17, 2008
- Terminated
- October 25, 2010
- Product code
- KGI – Densitometer, Bone
- Quantity
- 212 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-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-2187-2008 | Hologic Explorer 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 |