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U.S. Department of Health and Human Services

Class 2 Device Recall Fluoroscan Mini Carm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2

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  Class 2 Device Recall Fluoroscan Mini Carm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 see related information
Date Initiated by Firm April 25, 2013
Date Posting Updated May 17, 2013
Recall Status1 Terminated 3 on August 21, 2014
Recall Number Z-1327-2013
Recall Event ID 65028
510(K)Number K051025  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2

The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
Code Information Serial numbers per recall strategy.
Recalling Firm/
Manufacturer
Hologic, Inc.
35 Crosby Dr
Bedford MA 01730-1450
For Additional Information Contact Lida Reed
781-999-7300
Manufacturer Reason
for Recall
The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.
FDA Determined
Cause 2
Software design
Action The firm, Hologic, Inc. sent an "Urgent: Medical Device Recall" letter dated April 25, 2013, via FedEx to consignees/customers notifying them of the software defect and providing them with corrected user installable software version. The customers were instructed to complete and return the Enclosure to Customer Notification, Confirmation of Notification form via fax to Hologic at 866-652-8674 or mail the document to Hologic using the enclosed pre-addressed, pre-paid return envelope. Should you have any questions regarding this recall, require further information or assistance with the software installation call Hologic's Help Desk at 1-800-321-4659.
Quantity in Commerce 2780
Distribution Worldwide distribution: USA (nationwide) and countries of: DE, RU, AU, IT, GB, ES, FR, KR, ZA, CA, AR, LT, TW, CN, BE, AT, JP, QA, SA, SG, HK, SI, NL, and SE.
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.
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