“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
MAGNUS, concerning the extension device reference 1180.19X0
Product Description
The surgical table system is used for the placement and positioning of patients for surgical treatment immediately before, during and after the operative phase. The surgical table system is accompanied by a set of accessories that allows it to be configured to adapt to the different requirements of a wide range of surgical treatments.
The purpose of the surgical table is to support and position patients for surgeries, including radiological diagnoses immediately before, during and after procedures.
The surgical table and table for surgery, are operating tables electrohydraulic, designed to carry out virtually all types of surgical procedures in cardiology, vascular surgery, cardiovascular, endoscopy, gynecology, urology, endurology, nephrectomy, neurology, neurosurgery, ophthalmology, orthopedics , abdominal, cystoscopy, thoracic and kidney, gallbladder, decay replacement, pacemaker insertions, HICKMAN catheters, BROVIAC insertions, shunts, VCI filters, cholangiographies, lung biopsies, implant defibrillation, NISSEN fundoplication; orthopedic reconstructive and hip repair procedures and lower extremities: total anterior hip proximal arthroplasty (AATHA); hip fracture; Tibial fracture; pelvic and acetabular fracture; fracture of the femur, thoracic and lumbar spine; arthroscopy and coating, implantation of nails in the hip, nailing of ENDER, intramedullary nails for femur, surgery of the tibia and elperoné. With the complement of the accessories of the table STERIS or MEDILAND. They allow the positioning and flexible articulation of the patient subjected to a surgical operation, designed specifically to offer the total flexibility of positioning of the patient that is required in modern surgical centers. They provide flexible and easy-to-use articulation mechanisms for patient positioning in reconstructive and restorative orthopedic procedures.