澳大利亚自主研发的CellAED除颤仪存在严重安全隐患，制造商Rapid Response Revival仅用两头猪进行了测试，且测试中两头猪的心脏均未被成功复苏，但该设备仍被批准上市[1]。这款设备的能量仅为85焦耳，远低于澳大利亚除颤指南推荐的200焦耳标准[1]。
公司一位前高管曾在2019年和2021年两次向澳大利亚治疗商品管理局（TGA）举报该公司存在欺骗性融资和虚假声明，但监管部门未采取行动[1]。公司2019年的临床评估报告明确显示"迄今为止，未进行人体临床研究"[1]。英国标准机构因缺乏临床证据，于2023年后撤销了该设备的认证[1]。
目前，超过2.3万台CellAED设备已被销售或捐赠，其中包括维多利亚州和堪培拉的救护车服务[1]。2025年6月，制造商任命管理人进行关键召回，公司银行账户仅剩20澳元，同时欠债务人最高1,800万澳元[1]。
An Australian-developed defibrillator called CellAED has been distributed to over 23,000 locations despite significant safety red flags and minimal testing data, according to an investigation by the Sydney Morning Herald.[1] The device, manufactured by Rapid Response Revival, was tested on only two pigs, neither of which showed cardiac revival during the trials.[1] Despite this inadequate testing, the defibrillator received regulatory approval and has been deployed to ambulance services in Victoria and the Australian Capital Territory.[1]
The CellAED delivers only 85 joules of energy, substantially below the 200 joules recommended by Australian defibrillation guidelines.[1] A 2019 clinical evaluation report from the manufacturer acknowledged that "no human clinical studies have been conducted to date," yet the company proceeded to market and distribute the device widely.[1] A former executive raised concerns about the company's practices, filing complaints with the Therapeutic Goods Administration (TGA) in both 2019 and 2021 regarding deceptive financing claims and false statements, but the regulator took no action.[1] The United Kingdom's standards body withdrew the device's certification in 2023, citing insufficient clinical evidence.[1]
In June 2025, Rapid Response Revival appointed an administrator to oversee a critical recall after the company's financial situation became dire, with bank accounts containing only 20 Australian dollars and debts reaching up to 18 million Australian dollars.[1]