MyLab Gamma, Model 7410
FDA Device Recall #Z-0205-2019 — Class II — June 11, 2018
Recall Summary
| Recall Number | Z-0205-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 11, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ESAOTE S.P.A. |
| Location | Sesto Fiorentino, N/A |
| Product Type | Devices |
| Quantity | 10 |
Product Description
MyLab Gamma, Model 7410
Reason for Recall
The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring settings may not be effective in specific operating conditions so that the surface of the probe head may overheat in around one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue.
Distribution Pattern
Worldwide distribution - US Nationwide in the states of AK, AZ, CA, IN, MO, NM, PA, SC, and TX. and countries Argentina and Australia Austria Bangladesh Belgium Brazil Bulgaria China Costa Rica Denmark Egypt Finland France Germany Greece Hong Kong Hungary Iceland India Iran Italy Japan Kuwait Mexico Netherlands Norway Paraguay Poland Portugal Russian Fed. Saudi Arabia Singapore Slovenia South Africa South Korea Spain Switzerland Taiwan Thailand Tunisia Turkey United Kingdom Utd.Arab Emir.
Lot / Code Information
n/a
Other Recalls from ESAOTE S.P.A.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1490-2026 | Class II | Esaote Endocavity ultrasonic probe, Model E 3-1... | Mar 14, 2025 |
| Z-0204-2019 | Class II | MyLab Alpha, Model 7400 | Jun 11, 2018 |
| Z-0206-2019 | Class II | MyLab Seven, Model 6400 | Jun 11, 2018 |
| Z-1138-2018 | Class II | MyLab Ultrasound System; Models 6100, 6150, 620... | Jan 3, 2018 |
| Z-1137-2018 | Class II | MyLab Ultrasound System; Models 6100, 6150, 620... | Jan 3, 2018 |
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.