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U.S. Department of Health and Human Services

Class 2 Device Recall Fluoroscan Mini Carm InSight, software versions 1.x, 2.x, 3.x

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 Class 2 Recall
Fluoroscan Mini Carm InSight, software versions 1.x, 2.x, 3.x
see related information
Date Posted May 17, 2013
Recall Status1 Terminated on August 21, 2014
Recall Number Z-1326-2013
Recall Event ID 65028
Premarket Notification
510(K) Number
K051025 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x 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, Massachusetts 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
DESIGN: 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 287
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 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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