GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units), AMS Innovative Center, San Jose, CA 95134.
This recall has been terminated (originally issued March 20, 2008).
- Company
- Ams Innovative Center San Jose
- Recall Initiated
- April 17, 2007
- Posted
- March 20, 2008
- Terminated
- March 23, 2010
- Recall Number
- Z-0130-2008
- Quantity
- 169 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Component missing: Some products were issued without thermal protection switches.
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.
Lot / Code Info
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.
Root Cause
Process design
Action Taken
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.