Events

Recall of GreenLight HPS Surgical Laser System

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
    38336
  • Event Risk Class
    Class 2
  • Event Number
    Z-0130-2008
  • Event Initiated Date
    2007-04-17
  • Event Date Posted
    2008-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53454
  • 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
    Surgical Laser System - Product Code GEX
  • Reason
    Component missing: some products were issued without thermal protection switches.
  • Action
    AMS issued Important: Medical Device Correction letters, dated April 17, 2007, to its US and international consignees by mail, instructing them to return an acknowledgement form. The letter informs customers that some HPS systems may lack a motor overload switch, that the firm believes that there is no immediate safety issue, and installation of the MOL switch will be conducted during normal preventive maintenance. AMS expects to complete installation of the switches by end of August 2007.

Device

GreenLight HPS Surgical Laser System
  • Model / Serial
    Part number 001-0070. International parts get a part number designation of 0010-0075. Serial Numbers (All starting with HPS2): 125, 167, 057, 067, 072, 106, 114, 120, 149, 193, 186, 161, 037, 039, 040, 044, 050, 088, 185, 190, 197, 035, 160, 208, 046, 076, 102, 074, 108, 121, 141, 173, 178, 089, 069, 030, 155, 172, 174, 148, 042, 164, 098, 175, 100, 169, 196, 056, 071, 132, 165, 036, 201, 033, 123, 065, 206, 170, 179, 095, 177, 073, 194, 086, 064, 122, 133, 049, 060, 078, 112, 150, 163, 130, 059, 101, 113, 135, 146, 137, 189, 195, 063, 157, 181, 166, 052, 043, 061, 092, 124, 029, 096, 093, 094, 138, 202, 211, 129, 144, 058, 162, 168, 045, 085, 066, 082, 053, 140, 158, 159, 090, 182, 183, 051, 087, 104, 116, 117, 205, 034, 203, 222, 223, 226, 229, 207, 214, 220, 230, 070, 103, 215, 110, 068, 077, 079, 128, 153, 075, 080, 083, 084, 097, 176, 105, 134, 136, 143, 147, 111, 171, 131, 151, 156, 109, 180, 145, 062, 118, 126, 127, 152, 139, 142, 209, 081, 099, 119.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, Italy, France, Germany, Spain, UK, Denmark, Sweden, Australia, India, Japan, Greece, Switzerland, Saudi Arabia, Thailand, Turkey, Singapore, Taiwan/Hong Kong (China), and Austria.
  • Product Description
    GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units), AMS Innovative Center, San Jose, CA 95134.
  • 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