Quanta System Laser Surgical Instrument Recall for Promotional Material Claims
Quanta System is recalling 22 laser surgical instruments because website promotional materials contained claims not applicable to US 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 the source text identifies the issue as promotional material claims rather than a physical defect or contamination, aligning with the 'Moderate' criteria for minor labeling or documentation issues.
Plain-English summary
Quanta System, S.p.A. is recalling 22 units of the Ultrawave II EX 1320 and Ultrawave III EX 1320 Powered Laser Surgical Instruments. The recall is limited to the United States, with distribution reported in Texas, Arizona, Oregon, and Colorado.
The recall was initiated because the manufacturer's website contained promotional materials for products distributed in the U.S. that did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and consignees should stop using the affected promotional materials and contact Quanta System for further instructions. No specific instructions for end-users regarding the physical devices are provided in the source text beyond the notification to U.S. consignees.
The recalled product
- Product
- Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and psoriasis
- Manufacturer
- Quanta System, S.p.A.
- Hazard
- Affected units
- 22
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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