Z-1773-2013Class II

The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock...

Name: Z-1773-2013 The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock...
Creator: Physio Control, Inc.
Published: 2013-06-12
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2013-06-12 / Terminated / root cause: manufacturing process

FDA source

Physio Control, Inc. began a recall of The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes... on 2013-06-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1773-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-12
Posted: 2013-07-19
Terminated: 2013-09-19
Recalling firm: Physio Control, Inc.
Product: 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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Physio-Control Inc., contacted their consignees by telephone or email starting on June 13, 2013 and sent and/or delivered an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 2013 to its customers. The letter described the product, problem and actions to be taken. A Physio-Control representative will be contacting the customers by direct visit, telephone, or email you to coordinate the replacement of their device(s). Customers with questions regarding this notification, please call Physio's Technical Support at 1-800-442-1142, 6:00 a.m. to 4:00. pm. (Pacific), Monday-Friday.
Quantity in commerce: 139 total (125 units in the US and 14 units outside US)
Distribution: Worldwide distribution: US (nationwide) including states of: IL, MA, NC, ND, NY, PA, RI, TX, WA, and WI; and country of: Canada.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1773-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1773-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-19

Product code MKJ

K052057Class IIILifepak 500 Automated External DefibrillatorMedtronic Emergency Response Systems, Inc. / cleared 2006-02-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)