LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained me...
FDA Device Recall #Z-1144-2017 — Class II — January 16, 2017
Recall Summary
| Recall Number | Z-1144-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 16, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Physio-Control, Inc. |
| Location | Redmond, WA |
| Product Type | Devices |
| Quantity | 2584 units total (1501 units in the US; 1034 units international; and 49 units owned by Physio). 50 modules total |
Product Description
LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions.
Reason for Recall
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
Distribution Pattern
Worldwide distribution. LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia. LifePak 15 distributed nationwide in the US including Puerto Rico and to ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHILE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, FRENCH GUIANA, GERMANY, GREECE, HUNGARY, ICELAND, IRELAND, ITALY, LITHUANIA, LUXEMBOURG, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SENEGAL, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TAHITI, UNITED ARAB EMIRATES, AND UNITED KINGDOM.
Lot / Code Information
LOT NUMBERS OF AFFECTED MODULE: Lot # 1506, 1520, 1532, 1544, and 1551. SERIAL NUMBERS OF AFFECTED DEVICES: 37930990, 38046566, 38130282, 38200467, 38374121, 38544771, 38561025, 38567823, 38577667, 38763423, 38805573, 39229417, 39656903, 39749477, 39757723, 39757723, 39905189, 40007558, 40007616, 40008237, 40074226, 40246186, 40637428, 40639397, 40881488, 41119327, 41441205, 41734558, 41908077, 42036185, 42721982, 42759819, 43273957, 43981182, 44128955, 44143195, 44143356, 44143399, 44143438, 44143481, 44143616, 44143674, 44143708, 44143786, 44143811, 44143814, 44143891, 44143894, 44143984, 44146278, 44146304, 44146408, 44148345, 44148588, 44148641, 44150897, 44151007, 44151084, 44151151, 44151156, 44151224, 44151362, 44151498, 44151591, 44151697, 44151790, 44151809, 44151862, 44151920, 44151995, 44152133, 44152249, 44152345, 44152361, 44156527, 44157048, 44157124, 44157189, 44157404, 44157697, 44157711, 44158485, 44158543, 44158614, 44158707, 44158804, 44159096, 44159162, 44159337, 44159406, 44159406, 44159491, 44159555, 44159615, 44159786, 44160212, 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Other Recalls from Physio-Control, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1544-2026 | Class II | PHYSIO CONTROL INFANT/CHILD Reduced Energy Defi... | Jan 21, 2026 |
| Z-2498-2025 | Class II | LIFEPAK 1000 Part / Catalog Numbers / UDI-DI co... | Jul 22, 2025 |
| Z-2499-2025 | Class II | LIFEPAK CR2 Part / Catalog Numbers / UDI-DI co... | Jul 22, 2025 |
| Z-2497-2025 | Class II | LIFEPAK 15 Part / Catalog Numbers / UDI-DI code... | Jul 22, 2025 |
| Z-1232-2025 | Class II | LIFEPAK 20e REF 99507-000001 The AED mode is... | Feb 3, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.