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WHAT IS THIS?
A Recall is a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.
EVENT
| Type of Event | Recall |
|---|---|
| Recall Numbers | Z-1317-2025, Z-1316-2025, Z-1322-2025, Z-1323-2025, Z-1318-2025, Z-1319-2025, Z-1320-2025, Z-1321-2025 |
| Risk Class | Class 2 |
| Recall Qty | 198,059 |
| Classification Date | 2025-03-12 |
| Recall Link | Search FDA Site |
| Notes/Alerts | N/A |
| Recall Reason | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
DEVICE
| Manufacturer | Zoll Medical |
|---|---|
| Model Names | Powerheart G5 AED |
| Model Numbers | G5A-80A, G5A-80A-TSO, G5A-00A, G5A-01A, G5A-02A, G5A-03A, G5A-19A, G5S-00A-TSO, G5S-01A, G5S-02A, G5S-05A, G5S-08A, G5S-10A, G5S-11A, G5S-80A-TSO, G5S-80-L, G5S-90A, G5S-80A, G5A-80C, G5A-80C-TSO, G5A-01C, G5A-02C, G5A-05C, G5A-08C, G5A-10C, G5A-13C, G5A-15C, G5A-22C, G5A-41C, G5A-85C, G5A-90C, G5A-80-L, G5S-01C, G5S-02C, G5S-10C, G5S-11C, G5S-80C |
| Part/Item/Catalog/ REF/Product Number | |
| Device Description | |
| Serial Number(s) | Please refer to each individual recall for details. |
| Lot #/Exp Date(s) | N/A |
CUSTOMER/PATIENT ACTIONS
Customers who have AEDs should routinely:
(1) Monitor device for self-test results.
(2) For customers who experience a self-test failure, take action to resolve any alerts as soon as possible.
Customers who have at-risk devices should immediately:
(1) Communicate this notification to G5 AED users.
(2) Ensure users have a program in place that periodically monitors the status of these devices, in accordance with G5 User s Guide.
(3) EC 501 is likely due to exposure to humidity outside the device s published specification. Ensure devices are stored within the device s published specifications:
” Temperature: 0C to 50C (32F to 122F)
” Humidity: 10% to 95% (non-condensing)
(4) Respond to ZOLL via the customer notification form acknowledging that you have received this notice.
CONTACT INFORMATION
Report any adverse health consequences experienced with the use of this product to Zebra. Events may also be reported to the FDA’s MedWatch Adverse Event Reporting program via:
Web: MedWatch website at www.fda.gov/medwatch
Phone: 1-800-FDA 1088 (1-800-332-1088)
Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
