RegWardenFDA facility compliance records
Facility

QUANTA SYSTEM, S.P.A.

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2012: 1 recalls; 2021: 1 recalls1’12’13’14’15’16’17’18’19’201’21’22’23’24’25’26
  • Recalls (2)

Devices registered here (1)

  • Laparoscope, General & Plastic Surgery
    Product code GCJ (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500

Recalls & enforcement

  • Class IITerminated2021-04-27
    Product sterility is potentially compromised.
  • Class IITerminated2012-11-07
    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.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “QUANTA SYSTEM, S.P.A. (FEI 3004378299) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004378299-quanta-system-s-p-a/

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