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Terminated

Motorised Safety Filter, Wild; Model number 6339590. Intended for photocoagulation.

FDA Recall Z-0578-2010 · Posted 2010-01-20

Recalling FirmEllex Medical Pty Ltd
Recall StatusTerminated
Product CodeHQF
Date Initiated2009-02-11
Date Terminated2012-09-07
Product Quantity200 units total

Reason for Recall

Potential for two screws important in the design of the safety filter to come loose.

Firm Action

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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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