Home / Recalls / Quanta System, S.p.A. / Z-1843-2021

Z-1843-2021 Class II Terminated

Recalled by Quanta System, S.p.A. — Samarate, N/A

Recall Details

Product Type
Devices
Report Date
June 16, 2021
Initiation Date
April 27, 2021
Termination Date
September 5, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2427 units

Product Description

Quanta System Sterile Optical Laser Fiber, single use

Reason for Recall

Product sterility is potentially compromised.

Distribution Pattern

Nationwide distribution via 6 US distributors

Code Information

Product Part Numbers: OAF002011 - lots A194207, A194208, A194528, A194529, A201001, A201002 OAF005511 - lots A184635, A192114, A193613, A194527, A202027 OAF006001 - lots A183626 and A193106 OAF008001 - lot A193616 OAF009901 - lot A192911 and A193108 OAF009911 - lots A192914 and A202028 OAF302711 - lot A202029 OAF402011 - lots A380350, A384633, A392907 OAF702711 - lots A190301, A192113, A192906, A193110, A193111, A193112, A194108, A194211, A194532 OAF703611 - lots A180300, A190302, A190303, A192115, A192908, A193102, A193113, A194209, A194210, A195013, A195014

Other recalls by Quanta System, S.p.A.

  • Z-1844-2021 Class II — Quanta System Sterile Optical Laser Fiber, reusable (April 27, 2021)
  • Z-1842-2021 Class II — Olympus Sterile Optical Laser Fiber, single use and reusable (April 27, 2021)
  • Z-0692-2013 Class II — Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair r (November 7, 2012)
  • Z-0691-2013 Class II — Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatme (November 7, 2012)
  • Z-0693-2013 Class II — Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. (November 7, 2012)