The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0691-2013·Announced 2013-01-23

Quanta System Q-Plus T Laser Recall for Promotional Material Labeling

Quanta System is recalling 75 Q-Plus T laser units because promotional materials on their website did not specify that certain claims did not apply to U.S. distributed devices.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 and involves a labeling error regarding promotional claims. According to the rubric, minor labeling errors and voluntary precautionary recalls fall under the Moderate severity level.

Plain-English summary

Quanta System S.p.A. is recalling 75 units of the Q-Plus T Powered Laser Surgical Instrument. The recall involves a Class II classification and affects devices distributed worldwide, including in the United States (specifically Texas, Arizona, Oregon, and Colorado). Only the U.S. product is affected by this specific recall action.

The reason for the recall is that 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 labeling and documentation issue regarding the scope of promotional claims.

Consumers and consignees should be aware that the promotional materials on the manufacturer's website may contain claims that are not applicable to the devices distributed in the United States. The recall is limited to the promotional materials and the associated labeling clarity for the U.S. market.

The recalled product

Product
Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and…
Manufacturer
Quanta System, S.p.A.
Category
Medical Device — Laser Surgical Instrument
Hazard
Affected units
75

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

Distributed in 4 states:

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 →

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