Quanta System Laser Recall for Inaccurate Promotional Website Claims
Quanta System is recalling 12 Eterna Giovinezza laser units because its website contained promotional materials with claims not applicable to U.S. distributed devices.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II but involves a labeling and promotional materials error rather than a physical defect or reported injury, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Quanta System, S.p.A. is recalling 12 units of the Eterna Giovinezza System, a powered laser surgical instrument used for permanent hair reduction and dermatological treatments. The recall is due to promotional materials on the company's website that did not specify that certain claims were not meant to apply to devices distributed in the United States.
The affected devices were distributed worldwide, including in the United States, with specific mentions of Texas, Arizona, Oregon, and Colorado. Only the U.S. product is affected by this recall. The agency has classified this as a Class II recall.
Consumers and consignees should contact Quanta System, S.p.A. for further instructions regarding the promotional materials and device claims. No specific instructions for end-users to stop using the device are provided in the source text, as the issue pertains to website promotional content rather than a physical defect in the device itself.
The recalled product
- Product
- Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne
- Manufacturer
- Quanta System, S.p.A.
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All codes and devices are applicable.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Quanta System, S.p.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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