Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA.
FDA Recall Z-0286-2008 · Posted 2007-12-20
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Recalling FirmEllex USA
Recall StatusTerminated
Product CodeHQF
Date Initiated2007-06-13
Date Terminated2008-10-17
Product Quantity10
Reason for Recall
Electric Shock from Power Supply : The power supply has a defect which can cause an electrical shock to user.
Firm Action
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
Distribution Pattern
Worldwide Distribution - USA including states of WI, PA, CO, CA, NC, NY, SC, MD, and MS, and countries of Canada and Brazil.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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