Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model nu...
FDA Device Recall #Z-0348-2014 — Class II — November 6, 2013
Recall Summary
| Recall Number | Z-0348-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 6, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Candela Corporation |
| Location | Wayland, MA |
| Product Type | Devices |
| Quantity | 1258 units |
Product Description
Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040
Reason for Recall
Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.
Distribution Pattern
Worldwide distribution: US (nationwide) and Internationally to: Azerbaijan, Bulgaria, Chile, Czech Republic, Greece, Israel, Kuwait, Qatar, Saudi Arabia, Serbia, Turkey, and the United Arab Emirates and to Subsidiaries in Australia, France, Germany, Italy, Japan, Portugal, Spain, and the United Kingdom.
Lot / Code Information
GL Pro Model 9914-00-9015:: SN 9914-9015-0005 through 9914-9015-1259 GL Pro LE Model 9914-00-9040: SN 9914-9040-0716 through 9914-9040-1214
Other Recalls from Candela Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0206-2020 | Class II | Canister HFC-134a /1000g, ALUM Product Number:... | Sep 10, 2019 |
| Z-0207-2020 | Class II | Canister HFC-134a /1000g, ALUM, 15 pack Produc... | Sep 10, 2019 |
| Z-0208-2020 | Class II | Canister HFC-134a / 980g, ALUM Product Number:... | Sep 10, 2019 |
| Z-0209-2020 | Class II | Canister HFC-134a /980g, ALUM, 15 pack Product... | Sep 10, 2019 |
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.