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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

Product Description 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.
Recall Number Z-1773-2013
Classification Class II
Code Info 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.
Product Distributed Qty 139 total (125 units in the US and 14 units outside US)
Reason For Recall 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.

Event Detail

Event Id 65565
Product Type Devices
Status Ongoing
Recalling Firm Physio Control, Inc.
City Redmond
State WA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: US (nationwide) including states of: IL, MA, NC, ND, NY, PA, RI, TX, WA, and WI; and country of: Canada.
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