ModerateClass IITerminated

FDA Devices recall · Reported January 23, 2013

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; Treatment of benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser trea

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on January 23, 2013. Severity: Moderate. Recall number: Z-0693-2013.

Q: Where was the recalled product distributed?

Distribution: Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall..

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of…

Recall #: Z-0693-2013
Affected scope: 22 units
Initiated: November 7, 2012

Compiled from official public sources by the publisher. · Updated September 2026

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Quanta System, S.p.A. recalled Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 10… - a moderate-severity action.

Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 10… was recalled by Quanta System, S.p.A. in January 23, 2013. Reason: Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials f…. Check the official notice for the remedy. Verify recall #Z-0693-2013 with the FDA Devices before acting.

The recall

Quanta System, S.p.A. issued this moderate-severity FDA Devices recall-Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials f….

Moderate
severity level: 22 units
affected scope: Class II
classification: January 23, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0693-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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; Treatment of benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments; Treatment of facial wrinkles (e.g. periocular and periorbital); Removal of unwanted hair, for the stable longterm, or permanent, hair reduction, including Fitzpatrick IVI and suntanned skin types; For the treatment of pseudofolliculitis barbae (PFB); Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; For use on all skin types (Fitzpatrick IVI) including tanned skin. Alexandrite 755 nm: Coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types 1VI, including suntanned skin types; Pigmented lesions; Wrinkles. Nd: YAG 1320 nm: General surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue; Treatment of periorbital and periocular wrinkles, fine lines and wrinkles, treatment of back acne and atrophic acne scars. IPL: Permanent hair reduction; Photocoagulation of dermatological vascular lesion (i.e. face telangiectasia); Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions.

Reason for recall

Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0693-2013
Date reported	January 23, 2013
Date initiated	November 7, 2012
Recalling firm	Quanta System, S.p.A.
Firm location	Solbiate Olona (VA), N/A
Affected scope	22 units
Distribution	Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

22 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0693-2013) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on January 23, 2013. Severity: Moderate. Recall number: Z-0693-2013.

Where was the recalled product distributed? ▼

Distribution: Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

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This recall: FDA Devices, reported January 23, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026