The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and is intended for use in the pre-hospital and workplace and community environments.

Reason: The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable.

Code information: PART NUMBERS: 3011790-001568, 3011790-001574, 3011790-001627, 3011790-001634, and 3011790-001650. SERIAL NUMBERS OUTSIDE the US: 41232265, 41232267, 41232269, 41232270, 41232271, 41232272, 41238207, 41238208, 41301145, 41301370, 41301371, 41301372, 41301373, and 41301374. SERIAL NUMBERS IN THE US: 41134905, 41134906, 41134907, 41135982, 41135983, 41135984, 41135991, 41135992, 41135993, 41135994, 41135995, 41135996, 41135997, 41135998, 41135999, 41136000, 41136001, 41136002, 41136003, 41136004, 41136005, 41136006, 41136007, 41136008, 41136009, 41136010, 41136011, 41136012, 41136013, 41136014, 41136015, 41136016, 41136017, 41136018, 41136019, 41136020, 41136021, 41136022, 41136023, 41136024, 41136025, 41136026, 41136027, 41136028, 41136029, 41136030, 41136031, 41136033, 41136034, 41136035, 41136036, 41136037, 41136038, 41136039, 41136040, 41136060, 41136061, 41136062, 41136063, 41136064, 41136065, 41136066, 41136067, 41136068, 41136069, 41136070, 41136071, 41136072, 41136073, 41136074, 41136075, 41136076, 41136077, 41136078, 41136079, 41136092, 41136093, 41136094, 41142873, 41145359, 41145360, 41145361, 41145362, 41145363, 41145364, 41145365, 41145366, 41145367, 41145368, 41145369, 41145370, 41145371, 41145372, 41145373, 41145374, 41145375, 41145376, 41145377, 41145378, 41164115, 41232002, 41232003, 41232004, 41232005, 41232249, 41232250, 41232251, 41232252, 41232253, 41232254, 41232255, 41232256, 41232257, 41232258, 41232259, 41232260, 41232554, 41239182, 41239183, 41239184, 41239185, 41239186, 41239187, 41239188, and 41239189.

Distribution pattern: Worldwide distribution: US (nationwide) including states of: IL, MA, NC, ND, NY, PA, RI, TX, WA, and WI; and country of: Canada.