• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall GreenLight HPS Surgical Laser System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
GreenLight HPS Surgical Laser System
see related information
Date Posted March 20, 2008
Recall Status1 Terminated on March 23, 2010
Recall Number Z-0130-2008
Recall Event ID 38336
Premarket Notification
510(K) Numbers
K010284  K062719 
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units), AMS Innovative Center, San Jose, CA 95134.
Code Information 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.
Recalling Firm/
Manufacturer
AMS Innovative Center - San Jose
3070 Orchard Dr
San Jose, California 95134-2011
Manufacturer Reason
for Recall
Component missing: Some products were issued without thermal protection switches.
FDA Determined
Cause 2
DESIGN: Process Design
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.
Quantity in Commerce 169 units
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = LASERSCOPE
-
-