Devices

Device Recall MyCareLink Patient Monitor

  • 모델명 / 제조번호(시리얼번호)
    Model (UPN/GTIN): 24950 (00643169292284, 00643169292345, 00643169292260, 00643169292529, 00643169292208, 00643169292192, 00643169292222, 00643169292239, 00643169292321, 00643169292215, 00643169292246, 00643169409132, 00643169292253, 00643169292277, 00643169292291, 00643169292307, 00643169292314, 00643169292338); 24950D (643169467163, 00643169441484, 00643169441101, 00643169367173, 00643169367227, 00643169367159, 00643169409156, 00643169367296, 00643169367302, 00643169367258, 00643169367180, 00643169367166, 00643169367210, 00643169367289, 00643169409149, 00643169367197, 00643169367142, 00643169367241, 00643169367203); 24950D1 (00643169486744); 24950E (00643169493667, 00643169493681, 00643169493698, 00643169493674, 00643169451988, 00643169452015, 00643169452107, 00643169452039, 00643169452121, 00643169452008,  00643169452145, 00643169452046, 00643169452022, 00643169452053, 00643169452138, 00643169452060, 00643169451995, 00643169452114, 00643169452152, 00643169452077, 00643169452084, 00643169452091); 24950F (00643169545274, 00643169552074); 24950G (00643169663039 00643169624337, 00643169599987, 00643169599994, 00643169624368, 00643169624351, 00643169624344, 00643169552104); 24950GLQ (00643169552289, 00643169552050, 00643169552067); 24950J (00643169840591, 00643169658011, 00643169658066, 00643169657892, 00643169658073, 00643169786196, 00643169658059, 00643169658028, 00643169658004, 00643169657908, 00643169657915, 00643169657946, 00643169657953, 00643169657960, 00643169657977, 00643169657984, 00643169657991, 00643169657922, 00643169657939, 00643169658042, 00643169658080, 00643169658097, 00643169657885, 00643169705746, 00643169658035); 24950JLQ (00643169658127, 00643169658134, 00643169658141, 00643169947115, 00643169705753); 24950K (00643169725270, 00643169725324, 00643169725201, 00643169725355, 00643169725331, 00643169725317, 00643169725287, 00643169725263, 00643169725294, 00643169725218, 00643169725232, 00643169725249, 00643169725256, 00643169725225, 00643169725300, 00643169725348, 00643169725195); 24950KLQ (00643169725362, 00643169725379, 00643169725386)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Internationally: Austria, Belgium, Brunei, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lithuania, Malaysia, Malta, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, United Kingdom
  • 제품 설명
    MyCareLink Patient Monitors. || It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data to the physician or clinician.
  • Manufacturer
    Medtronic Inc., Cardiac Rhythm and Heart Failure
  • 1 Event

제조사

Medtronic Inc., Cardiac Rhythm and Heart Failure
  • 제조사 주소
    Medtronic Inc., Cardiac Rhythm and Heart Failure, 8200 Coral Sea St NE, Mounds View MN 55112-4391
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA