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Leak）、通信・伝送の問題（Communication or Transmission Problem）、漏れ・飛散（Leak\u002FSplash）が挙げられています。回収については、該当する事例は確認されていません。",{"pma":138,"k510":142,"as_of":143,"events":144,"recalls":148,"top_problems":150},{"latest":139,"originals":140,"supplements":141},"2025-12-16",1,8,{"total":31,"last5y":31,"latest":32,"applicants":31},"2026-08",{"death":140,"other":31,"total":34,"injury":145,"last5y":34,"malfunction":146,"latest_month":147},2,15,"2026-01",{"total":31,"last5y":31,"latest":32,"class_i":31,"class_ii":31,"class_iii":31,"top_root_causes":149},[],[151,152,153],"Fluid\u002FBlood Leak","Communication or Transmission Problem","Leak\u002FSplash","26b7ab16f0e63e04143435ce21a2f99f3b9b3611a21419e6cd7ee481f9796150","2026-08-24T05:16:12.270965+00:00",{"items":157,"total":31},[],{"items":159,"total":31},[],{"items":161,"total":33},[162,166,170,174,177,180,183,187,191],{"pma_number":24,"supplement_number":163,"trade_name":164,"applicant":165,"decision_date":139},"S009","Organ Care System (OCS) 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