Events

Recall of Device Recall GreenLight HPS Fiber Optics, Model Number 102090

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AMS Innovative Center - San Jose.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56418
  • Event Risk Class
    Class 2
  • Event Number
    Z-2502-2010
  • Event Initiated Date
    2010-01-22
  • Event Date Posted
    2010-09-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93604
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Powered Laser Surgical Instrument - Product Code GEX
  • Reason
    Product may be packed with incorrect external or internal labels and/or missing product insert.
  • Action
    Notification issued via letter with instructions and response sheet through certified mail on 01/12/2010.

Device

Device Recall GreenLight HPS Fiber Optics, Model Number 102090
  • Model / Serial
    Manufactured between August 21 and October 31, 2009-- Lot number/Affected units: 932: D, N, U, Z; 933: A, C, F, H, K, L, M, T; 934: B, D, N, U, V, W, Y, Z; 935: A, C, F, H, K, L, M, T; 936: B, D, N, U, V, W, Y, Z; 937: A, C, F, H, K, L, M, T; 938: B, D, N, U, V, W, Y, Z; 939: A, B,L, M, T, V, W, Y; 940: B, D, N, U, V, W, Y, Z.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 148 medical facilities throughout the US. and 6 consignees in Great Britain, Canada and Australia.
  • Product Description
    GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose, CA. Potentially Mislabeled as GreenLight PV 10-2079
  • Manufacturer
    AMS Innovative Center - San Jose

Manufacturer

AMS Innovative Center - San Jose
  • Manufacturer Address
    AMS Innovative Center - San Jose, 3070 Orchard Dr, San Jose CA 95134-2011
  • Source
    USFDA