510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0130-2008

GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075...

American Medical Systems Innovation Center - Silicon Valley / initiated 2007-04-17 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

AMS Innovative Center - San Jose began a recall of GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units), AMS Innovative Center, San Jose, CA... on . The reason FDA records is "Component missing: Some products were issued without thermal protection switches". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0130-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
American Medical Systems Innovation Center - Silicon Valley
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.
Product code
GEX Powered Laser Surgical Instrument
Reason for recall
Component missing: Some products were issued without thermal protection switches.
Root cause tag
manufacturing process
FDA root cause
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.
Product codes and lots
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.