U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
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.
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.
제품 설명
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.