Recall Z-0130-2008 ยท GEX Powered Laser Surgical Instrument
AMS Innovative Center - San Jose
GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units), AMS Innovative Center, San Jose, CA 95134.
| Date | Mar 20, 2008 (initiated Apr 17, 2007) |
| Status | Terminated |
| Reason | Component missing: Some products were issued without thermal protection switches. |
| 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 | 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. |
| FDA record | Open on fda.gov |