Z-2186-2008

Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate...

Name: Z-2186-2008 Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate...
Creator: Hologic, Inc.
Published: 2008-06-27
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2008-06-27 / Terminated / root cause: software

FDA source

Hologic, Inc. began a recall of 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... on 2008-06-27. The reason FDA records is "Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2186-2008
Status: Terminated
Initiated: 2008-06-27
Posted: 2008-09-17
Terminated: 2010-10-25
Recalling firm: Hologic, Inc.
Product: 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.
Product code: KGI Densitometer, Bone
Reason for recall: Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 82 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
Product codes and lots: 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

Product code KGI

K072847Class IIApex 2.0 Software for Qdr X-Ray Bone DensitometersHologic, Inc. / cleared 2008-03-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)