FDA Medical Device Recalls (openFDA)
Hologic, Inc.: Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
- Recall number
- Z-2453-2012
- Recalling firm
- Hologic, Inc.
- Product
- Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
- Status
- Terminated
- Initiated
- 2012-09-14
- Posted
- 2012-09-25
- Terminated
- 2014-01-10
- Reason
- Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180 around vertical axis as well as 180 around a horizontal axis.
- Root cause
- Software design
- Action
- Hologic issued an Urgent: Medical Device recall letter dated September 14, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Halogen corrected the anomaly and they provided the customer with the revised version of the software. Customers were asked to update their systems in accordance with the instructions provided with the software included with the letter. Customers were also asked to complete the attached acknowledgement form and fax or mail it to the firm at their earliest convenience. For any questions customers were instructed to call Hologic's Help Desk at 1-800-321-4659. For questions regarding this recall call 781-999-7300.
- Quantity
- 46 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia,Belgium, Canada, China, Germany, Ecuador, Spain, France, Great Britain, Greece, Hong Kong, Italy, Japan Korea, Lithuvania, Neherlands, qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan, South Africa, and Switzerland.
- Lot, serial or model codes
- Software version 5.0.1and 5.0.2
- 510(k) numbers
- ["K051025"]
- PMA numbers
- not on file
- Product code
- JAA
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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