The Recall Desk

Manufacturer

Quanta System, S.p.A.

6 recalls in our database name Quanta System, S.p.A. as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2021-06-16

Of the 6 recalls from Quanta System, S.p.A. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • HighFDA (Devices)·Z-1842-2021·2021-06-16

    FDA Recalls Olympus Sterile Optical Laser Fibers for Potential Sterility Compromise

    Quanta System is recalling Olympus Sterile Optical Laser Fibers nationwide due to potentially compromised sterility. Approximately 26,925 units distributed through six U.S. distributors are affected.

    Product
    Olympus Sterile Optical Laser Fiber, single use and reusable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2021·2021-06-16

    Quanta System Sterile Optical Laser Fiber Recall for Potential Sterility Compromise

    Quanta System is recalling 307 reusable sterile optical laser fibers nationwide due to potential sterility compromise. The affected devices were distributed through six U.S. distributors.

    Product
    Quanta System Sterile Optical Laser Fiber, reusable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0692-2013·2013-01-23

    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.

    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
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0693-2013·2013-01-23

    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.

    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
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0691-2013·2013-01-23

    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.

    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 abla
    Category
    Medical Device
    Distribution
    4 states