The RESPIRONICS V60 ventilator is a support ventilator whose purpose is to increase the patient's breathing. It is indicated for patients who can breathe spontaneously but require mechanical ventilation: patients with chronic respiratory insufficiency or obstructive sleep apnea in a hospital or other institution under the supervision of a doctor. The RESPIRONICS V200 fan is a mechanical fan that works with electricity and is controlled by a microprocessor. It has been designed to be used by qualified medical personnel to provide continuous or intermittent ventilatory support for adult, pediatric and neonatal patients according to medical prescription.
“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.