Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).
Reason for recall: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings). Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK, United Arab Emirates. Quantity: 3,177 units Lot/code info: UDI/DI 05414734509169, Serial Numbers: M131100003, M131100004, M131100008, M131100012, M131100013, M131100015, M131200018, M131200022, M131200027, M131200030, M131200033, M131200034, M131200035, M131200036, M131200038, M131200040, M131200043, M131200044, M131200047, M131200048, M131200050, M131200051, M131200052, M131200053, M131200054, M131200057, M131200059, M131200063, M131200066, M131200067, M131200069, M131200070, M131200071, M131200072, M131200073, M131200074, M131200075, M131200076, M131200077, M131200078, M131200079, M131200082, M131200083, M131200085, M131200086, M131200088, M131200090, M131200092, M131200094, M131200095, M131200096, M131200097, M131200099, M131200100, M131200102, M131200103, M131200105, M131200106, M131200108, M131200109, M131200110, M131200111, M131200116, M131200117, M131200118, M131200120, M131200123, M131200128, M131200129, M131200130, M131200134, M131200135, M131200136, M131200137, M131200139, M131200140, M131200142, M131200143, M131200144, M131200145, M131200148, M131200150, M140100158, M140100160, M140100161, M140100163, M140100165, M140100166, M140100167, M140100168, M140100170, M140100176, M140200250, M140200252, M140200254, M140200256, M140200257, M140200258, M140200259, M140200260, M140200261, M140200263, M140200264, M140200266, M140200269, M140200270, M140200271, M140200274, M140200276, M140200279, M140200280, M140200287, M140200288, M140200289, M140200291, M140200293, M140200294, M140200295, M140200299, M140200300, M140200301, M14020030
05414734509169
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.