Ellex Medical Pty Ltd Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation.
Brand
Ellex Medical Pty Ltd
Lot Codes / Batch Numbers
Solitaire LP4532 photocoagulator.
Products Sold
Solitaire LP4532 photocoagulator.
Ellex Medical Pty Ltd is recalling Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation. due to Potential for two screws important in the design of the safety filter to come loose.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for two screws important in the design of the safety filter to come loose.
Recommended Action
Per FDA guidance
Ellex issued a bulletin stating the problem and identifying the affected products. Customers are to remove the Motorised Safety Filter from clinical use if the green laser light is visible while viewing through the microscope at any time during use of the Solitaire laser. The Bulletin also states that customers should contact an Ellex approved Service Engineer to investigate and perform the Field Corrective Action listed. The manufacturer will remedy the defect or bring the product into compliance free of charge. Ellex will inspect and rework all affected safety filters sold prior to February 2009.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026