Ellex Integre Duo, Model No: LP1RG - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA. (The Integre Duo is a dual-wavelength surgical photocagulator laser intended for use in a clinic, outpatient clinic, or a retinal specialist's office. )
Recall
- Recall Number
- Z-0287-2008
- Event Number
- 45499
- Firm
- Ellex USA
- Product Code
- HQF
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- June 13, 2007
- Posted
- December 20, 2007
- Terminated
- October 17, 2008
- Address
- 7138 Shady Oak Road, Eden Prairie, MN, 55344
Description
Ellex Integre Duo, Model No: LP1RG - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA. (The Integre Duo is a dual-wavelength surgical photocagulator laser intended for use in a clinic, outpatient clinic, or a retinal specialist's office. )
Electric Shock from Power Supply: The power supply has a defect which can cause an electrical shock to user.
Ellex, Inc. called each customer on 6/13/07, about the problem (defect which can cause electric shock) and advised that they would be performing modification of the power supply in the laser system and scheduling a field service visit to complete the work. Upon completion of the modification, the service technician completed the service record and left a copy with each client and informed them of the completed work. A copy of each completed service record was sent to Ellex Medical Pty. Ltd. On 9/27/07, Ellex sent a letter to all consignees, informing them that all modifications by service technicians' have been completed, and that their Solitaire LP4532 laser and/or Intregre Duo LP1RG is up to the manufacturers specifications and is in good operating order.
Worldwide Distribution - USA including states of WI, PA, CO, CA, NC, NY, SC, MD, and MS, and countries of Canada and Brazil.
1