Z-2452-2012Class II

Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm...

Name: Z-2452-2012 Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm...
Creator: Hologic, Inc.
Published: 2012-09-14
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2012-09-14 / Terminated / root cause: software

FDA source

Hologic, Inc. began a recall of Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide... on 2012-09-14. FDA classified it as Class II and gives the reason as "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...". 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-2452-2012
Classification: Class II
Status: Terminated
Initiated: 2012-09-14
Posted: 2012-09-25
Terminated: 2014-01-10
Recalling firm: Hologic, Inc.
Product: Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 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.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: 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 tag: software
FDA 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 in commerce: 414 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.
Product codes and lots: Software version 4.0 and 4.0.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2452-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2452-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-25
Z-2453-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-25

Product code JAA

K051025Class IIFluoroscan Insight Mini C-Arm Fluoroscopic Imaging SystemHologic, Inc. / cleared 2005-05-13

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)