Z-1728-2009

Hologic Delphi series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of...

Name: Z-1728-2009 Hologic Delphi series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of...
Creator: Hologic, Inc.
Published: 2009-04-07
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2009-04-07 / Terminated / root cause: design

FDA source

Hologic, Inc. began a recall of Hologic Delphi series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of bone mineral density (BMD), comparison of... on 2009-04-07. The reason FDA records is "System may not turn off at the end of the x-ray and cause additional x-ray exposure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1728-2009
Status: Terminated
Initiated: 2009-04-07
Posted: 2009-08-25
Terminated: 2010-11-29
Recalling firm: Hologic, Inc.
Product: Hologic Delphi series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR 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: System may not turn off at the end of the x-ray and cause additional x-ray exposure
Root cause tag: design
FDA root cause: Component design/selection
Action: Hologic issued an Urgent: Medical Device Recall customer notification letter, dated April 17, 2009, by certified mail to inform customers of the problem. With the notification letter, customers will receive the following: -Software version Apex 12.6.2, 2.3.2, or 2.4.2 -Instructions to upgrade their systems with the provided software and to verify the new version on the system as a confirmation that the software was successfully loaded. -New Operator's Manual for installations where the operating characteristics of the system have changed due to the software upgrade. For Customers with systems with software versions other than 12.6, 2.3, or 2.4: Customers were asked to upgrade their QDR software, return their old QDR software disk, and complete and return to Hologic the enclosed Confirmation of Notification.
Quantity in commerce: 1914 units total
Distribution: Worldwide Distribution -- USA, Canada, Europe, Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Great Britain, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, Uzbekistan, Algeria, Arab Emirates, Argentina, Australia, Bahrain, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Hong Kong, Indonesia, India, Iran, Iraq, Israel, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Malaysia, Morocco, Mexico, Pakistan, Peru, Puerto Rico, South Africa, Saudia Arabia, Singapore, Syria, Taiwan, Thailand, Tunisia, Venezuela, and Vietnam.
Product codes and lots: S/N: 70638A 70756 70387C 71202W, and 70089W.

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)