Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 500
FDA device recall Z-0286-2008 · posted 2007-12-20 · Terminated
Recall details
- Recalling firm
- Ellex USA
- Reason for recall
- Electric Shock from Power Supply : The power supply has a defect which can cause an electrical shock to user.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HQF
- Quantity affected
- 10
- Distribution
- Worldwide Distribution - USA including states of WI, PA, CO, CA, NC, NY, SC, MD, and MS, and countries of Canada and Brazil.
- Date initiated
- 2007-06-13
- Date posted
- 2007-12-20
- Date terminated
- 2008-10-17
- Location
- Eden Prairie, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LASEREX, MODEL LP4532 (K041598) | Ellex Medical Pty, Ltd. | 2004-10-06 |