Hologic, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Hologic, Inc.
Lot Codes / Batch Numbers
S/N: 70638A 70756 70387C 71202W, and 70089W.
Products Sold
S/N: 70638A 70756 70387C 71202W, and 70089W.
Hologic, Inc. is recalling Hologic Delphi series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the esti due to System may not turn off at the end of the x-ray and cause additional x-ray exposure. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
System may not turn off at the end of the x-ray and cause additional x-ray exposure
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026