Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software ...
FDA Device Recall #Z-1311-2014 — Class II — March 5, 2014
Recall Summary
| Recall Number | Z-1311-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 5, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ZOLL Medical Corporation |
| Location | Chelmsford, MA |
| Product Type | Devices |
| Quantity | 3,169 units |
Product Description
Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
Reason for Recall
Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Canada, AE, Afganistian, Australia, Belgium, Czech Republic , China, Chile, Croatia, Denmark, France, Great Britain, Hungary, Israel, Italy, Japan, Korea, Kuwait, Russia, Saudi Arabia, Singapore, South Africa,Thailand, and Turkey.
Lot / Code Information
System Software Version 02.10.02.00 or Higher
Other Recalls from ZOLL Medical Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1317-2025 | Class II | Brand Name: ZOLL Product Name: Powerheart G5 A... | Feb 13, 2025 |
| Z-1316-2025 | Class II | Brand Name: ZOLL Product Name: Powerheart G5 A... | Feb 13, 2025 |
| Z-1319-2025 | Class II | Brand Name: ZOLL Product Name: Powerheart G5 A... | Feb 13, 2025 |
| Z-1318-2025 | Class II | Brand Name: ZOLL Product Name: Powerheart G5 A... | Feb 13, 2025 |
| Z-1321-2025 | Class II | Brand Name: ZOLL Product Name: Powerheart G5 A... | Feb 13, 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.