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.
FDA Recall Z-2187-2008 · Posted 2008-09-17
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Recalling FirmHologic, Inc.
Recall StatusTerminated
Product CodeKGI
Date Initiated2008-06-27
Date Terminated2010-10-25
Product Quantity325 units
Reason for Recall
Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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