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Class 2 Device Recall Hologic Fluoroscan Mini CArm Model with InSight FD |
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Date Initiated by Firm |
September 14, 2012 |
Date Posted |
September 25, 2012 |
Recall Status1 |
Terminated 3 on January 10, 2014 |
Recall Number |
Z-2453-2012 |
Recall Event ID |
63180 |
510(K)Number |
K051025
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Product Classification |
System, x-ray, fluoroscopic, image-intensified - Product Code JAA
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Product |
Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2
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 5.0.1and 5.0.2 |
Recalling Firm/ Manufacturer |
Hologic, Inc. 35 Crosby Dr Bedford MA 01730-1450
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For Additional Information Contact |
SAME 781-999-7300
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Manufacturer Reason for Recall |
Fluoroscan Mini C-Arm models -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.
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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 |
46 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
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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.
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510(K) Database |
510(K)s with Product Code = JAA and Original Applicant = HOLOGIC, INC.
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