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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 Recall
Hologic Fluoroscan Mini CArm Model with InSight2
see related information
Date Posted September 25, 2012
Recall Status1 Terminated on January 10, 2014
Recall Number Z-2452-2012
Recall Event ID 63180
Premarket Notification
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/
Manufacturer
Hologic, Inc.
35 Crosby Dr
Bedford, Massachusetts 01730-1450
For Additional Information Contact SAME
781-999-7300
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = HOLOGIC, INC.
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