Device recall: Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented…
Class II FDA enforcement event 64039. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
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
Quanta System, S.p.A. started this device recall on 7 Nov 2012. The firm address in the FDA record is in Solbiate Olona (VA). FDA put the recall in Class II. FDA event 64039 has 3 product records. The first FDA enforcement report date is 23 Jan 2013. The record gives the status Terminated, with the termination date 23 Jan 2013.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.
Recalling firm
Quanta System, S.p.A., Solbiate Olona (VA), N/A, Italy.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0691-2013 | 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 ablation of soft tissue; Tattoo removal;… | 75 units | Class II | Terminated | 23 Jan 2013 |
| Z-0692-2013 | 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 | 12 units | Class II | Terminated | 23 Jan 2013 |
| Z-0693-2013 | 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… | 22 units | Class II | Terminated | 23 Jan 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2012
- 823
- Share of these events in Class II
- 88%
- Product records in this event
- 3Median of the firm: 3
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Apr 2021 | Olympus Sterile Optical Laser Fiber, single use and reusable | Device | Class II | 3 |
Official channels
- FDA enforcement report Z-0691-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 64039. https://recallregister.com/fda/ii/64039/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.
- What quantity of product is in FDA event 64039?
- The event has 3 product records. The first record gives this quantity:
75 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2012 have the same class?
- 88% of the 823 device events that started in 2012 are in Class II.