Data Foundry

Medical device recalls 2013

The LIFEPAK 500 Automated External Defibrillator is a semi-automatic… — Class II medical device recall Z-1773-2013

Terminated recall by Physio Control, Inc., reported 2013-07-31, distributed nationwide. The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly

Recall numberZ-1773-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhysio Control, Inc., Redmond, WA, United States
Recall initiated2013-06-12
Classified2013-07-19
Reported by FDA2013-07-31
Terminated2013-09-19
DistributedNationwide (US)
Countries outside the USCA
Reason classesdevice malfunction
Serial numbers41134905, 41134906, 41134907, 41135982, 41135983, 41135984, 41135991, 41135992, 41135993, 41135994, 41135995, 41135996, 41135997, 41135998, 41135999, 41136000, 41136001, 41136002, 41136003, 41136004, 41136005, 41136006, 41136007, 41136008, 41136009 and 100 more
Model numbers3011790-001568, 3011790-001574, 3011790-001627, 3011790-001634, 3011790-001650

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1773-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.