Hologic Delphi 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.
This recall has been terminated (originally issued September 17, 2008).
- Company
- Hologic, Inc.
- Recall Initiated
- June 27, 2008
- Posted
- September 17, 2008
- Terminated
- October 25, 2010
- Recall Number
- Z-2186-2008
- Quantity
- 82 units
- Firm Location
- Bedford, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
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
Lot / Code Info
S/N: 70411W 70456W 71132C 71132C 71205W 70007C 70024C 70102C 70129C 70138C 70351C 70379A 70394A 70395C 70414A 70415A 70418A 70419A 70421A 70434W 70512A 70525W 70545W 70561W 70603W 70609C 70677C 70678W 70717C 70721W 70724A 70734A 70744C 70761C 70791C 70817W 70824C 70845C 70855SL 70896SL 70987W 71016C 71035W 71076C 71091C 71151C 71172SL 71188C 71223C 71231W 71239C 71255W 71257C 71287C 71342C and 71386C
Root 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.