“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.
Model# Serial Numbers M3535A US00100100 to US00602546 M3535ATZ US00100100 to US00602546 M3536A US00100902 to US00602540 (M3536ATZ) US00100902 to US00602540 M3536M US00500002 to US00553553 M3536MC US00500001 to US00500087 M3536M2 US00554176 to US00554178 M3536M3 US00571854 to US00588995 M3536M4 US00500003 to US00590982 M3536M5 US00500001 to US00587771 M3536M6 US00554358 to US00600582 M3536M7 US00581047 to US00601962 M3536M8 US00590958 to US0059095 M3536M9 US00581048 to US00581049
No U.S. distribution, Internationally to: India, Ireland, Japan, Republic of Korea, Malaysia, Mexico, South Africa & United Kingdom
Description du dispositif
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 || Product Usage: || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 || Product Usage: || The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart as well as for portable emergency response throughout a hospital.
HeartStart XL+ Defibrillator/Monitor,All Chinese XL manufactured before September, 2017, unless the XL+ is affected by F5N86100172, and has not been updated.
HeartStart XL+ Defibrillator/Monitor || The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AED. When operating in Monitor, Manual Defib, or Pacer Mode, the HeartStart XL+ is suitable for use by healthcare professionals trained in advanced life support.