FDA Device recall Z-1773-2013
The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System
- FDA Device
- Class II
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class II recall of The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System by Physio Control, citing 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 s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1773-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-12 |
| Published | 2013-07-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Physio Control |
| Distribution | US |
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
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.
Identifiers
| code_info | PART NUMBERS: 3011790-001568, 3011790-001574, 3011790-001627, 3011790-001634, and 3011790-001650. SERIAL NUMBERS O…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Physio Control
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FDA Device · Class II · 2026-03-18 · Physio Control - LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indi…
FDA Device · Class II · 2025-09-10 · Physio Control - LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-…
FDA Device · Class II · 2025-09-10 · Physio Control - LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 33…
FDA Device · Class II · 2025-09-10 · Physio Control
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1773-2013%22
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