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U.S. Department of Health and Human Services

Class 2 Device Recall Hologic Fluoroscan Mini CArm Model with InSight2

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  Class 2 Device Recall Hologic Fluoroscan Mini CArm Model with InSight2 see related information
Date Initiated by Firm September 14, 2012
Date Posting Updated September 25, 2012
Recall Status1 Terminated 3 on January 10, 2014
Recall Number Z-2452-2012
Recall Event ID 63180
510(K)Number K051025  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
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.
Code Information Software version 4.0 and 4.0.1
Recalling Firm/
Hologic, Inc.
35 Crosby Dr
Bedford MA 01730-1450
For Additional Information Contact SAME
Manufacturer Reason
for Recall
InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = HOLOGIC, INC.