LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: ...
FDA Device Recall #Z-1993-2016 — Class II — January 27, 2016
Recall Summary
| Recall Number | Z-1993-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 27, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Physio-Control, Inc. |
| Location | Redmond, WA |
| Product Type | Devices |
| Quantity | 44798 units total (23189 units in US; 21609 units international) |
Product Description
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
Reason for Recall
The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partially obscure a portion of the leading digit of the EtC02 value. This affects all LIFEPAK 15 with an EtC02 feature installed and configured to the kPa or % setting.
Distribution Pattern
Worldwide Distribution - US (nationwide) including Guam and Puerto Rico and Internationally to ¿land Islands, Algeria, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Barbados, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Cambodia, Canada, Cayman Islands, Chile, China, Costa Rica, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Eritrea, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guinea, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, the former Yugoslav Republic of, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Morocco, Mozambique, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Panama, Papua New Guinea, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Province of China, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Yemen.
Lot / Code Information
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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.