LifePAK 500 Automated External Defibrillator — Class II medical device recall Z-1633-2020
Terminated recall by Physio-Control, Inc., reported 2020-04-08, distributed nationwide. Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the co
| Recall number | Z-1633-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Physio-Control, Inc., Redmond, WA, United States |
| Recall initiated | 2020-03-20 |
| Classified | 2020-04-01 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2024-01-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BB, BE, BH, BM, BO, BR, BS, CA, CH, CL, CN, CY, CZ, DE, DK, DO, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HT, HU, ID, IE, IL, IN, IQ, IR, IT, JM, JO, JP, KE, KR, KW, KY, LB, LK, LT, LV, MX, MY, NG, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, SV, TR, TW, UA, UY, VE, VN, ZA |
| Quantity | 173,459 units |
| Model numbers | 3005400-XXX, 3011790-XXX, U3005400-XXX, U3011790-XXX |
Product
LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED 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 it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient.
Reason for recall
Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which could result in a delay in treatment
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-1633-2020. 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.