FDA Medical Device Recalls (openFDA)
Hologic, Inc.: Hologic Oasis 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.
- Recall number
- Z-2188-1991
- Recalling firm
- Hologic, Inc.
- Product
- Hologic Oasis 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.
- Status
- Terminated
- Initiated
- 2008-06-27
- Posted
- 2008-09-17
- Terminated
- 2010-10-25
- Reason
- Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
- 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
- 15 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
- Lot, serial or model codes
- S/N: 11/01/06 B 1/04/08B 11/01/06 A 6/24/05-A 9/25/06-01 9/25/06-02 9/25/06-03 9/25/06-04 9/28/06-01 9/28/06-02 9/28/06-03 9/12/07B 10/02/07B 10/02/07A and 1/04/08A
- 510(k) numbers
- ["K072847"]
- PMA numbers
- not on file
- Product code
- KGI
- Firm FEI
- 1221300
- Firm city
- Bedford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28