The first level recall notice of medical devices issued by FDA involves Philips, Abbott and Medtronic

Compiling coco This week, the US FDA issued three class I recall notices for medical devices, involving products from Abbott, Philips Medical and Medtronic Category I recall is the most serious type of recall in China and the United States, which means the use of these medical devices may lead to serious personal injury or even death From the FDA website On November 4, FDA notified the recall of 381 CentriMag acute circulation support systems (Lot No.: l05333-0001-l06608-0024) manufactured by Abbott in the United States, with the release date from November 22, 2017 to August 6, 2019 CentriMag system is used to pump blood to the patient during cardiac surgery, which can last up to 6 hours; it can also provide temporary blood circulation support for patients with cardiogenic shock for up to 30 days, that is, when the right side of the patient's heart loses pumping power and the blood flows back to the body's veins (acute right heart failure), the patient can use up to 30 days The system includes a control console to control the speed and flow of the pump, and a cable to connect the control console to the motor, so that the position of the pump motor and pump can be flexibly selected The main reason for the recall is the calibration system error of the equipment caused by electromagnetic interference, which may cause the pump to slow down or stop, the console screen to become blank and various inaccurate alarms If the pump slows down or stops, there may be adverse consequences for the patient, such as stroke, serious organ damage or even death Abbott's recall was launched in August 2019, when 44 people were reported injured and one died This product has not been launched in China On the same day, FDA also notified the recall of 852 Philips Medical Forte gamma camera systems in the United States, including: Forte (882020) Forte Jetstream (882290) Forte Jetstream upgrade (882291) Forte Jetstream AZ (882320) Forte Jetstream AZ upgrade (882321) Diamond Select Forte (889456) Diamond Select Forte JETStream (889471) The production and manufacturing date is from January 1, 1998 to December 31, 2008 It is reported that medical institutions use Philips Medical Forte gamma camera system to view images of patients' internal structure or function for diagnosis, design of treatment plans and evaluation of diseases Prior to the test, the patient will receive a contrast agent that will be used as part of the imaging examination The Forte gamma camera system was recalled because the detector, which weighs 660 pounds, could be separated from the device without any warning and could cause serious injury, such as crushing, trapping the patient, or death Philips Medical has received a customer complaint before, and so far no serious injuries or deaths have been reported The company, which launched a recall in September, has stopped using the Forte gamma camera system until it is corrected On November 5, the U.S FDA renewed a recall notice, recalling 1117 MiniMed 500 remote controls and 503 remote transmitters (mmt-500 and mmt-503) produced by Medtronic in the United States, with the equipment release date from August 6, 1999 to July 24, 2018 It is understood that the recalled device is part of the MiniMed insulin pump, which includes a remote control designed to communicate wirelessly with the pump to deliver a specific amount of insulin to diabetic patients MiniMed insulin pump recalled by Medtronic Due to potential network security risks, unauthorized persons (involving people other than patients, caregivers or healthcare providers) may record and reset wireless communication between the remote control and the MiniMed insulin pump It is reported that other people can instruct the insulin pump to over deliver insulin to the patient, resulting in hypoglycemia, or stop insulin delivery, resulting in hyperglycemia, diabetic ketoacidosis, or even death Medtronic began to recall the designated insulin pump in August 2018, and again issued a security alert in June this year, reminding hackers of the possibility of accessing and changing its insulin pump equipment So far, FDA has not found any patient injury reports related to these potential cyber security risks Some of the products involved in this time have been listed in China, and Medtronic China has previously prompted domestic attention to MiniMed Gamma 508 and MiniMed Gamma Paradigm Gamma 712, 712e, 722 insulin pumps.