Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation.
FDA device recall Z-0577-2010 · posted 2010-01-20 · Terminated
Recall details
- Recalling firm
- Ellex Medical Pty Ltd
- Reason for recall
- Potential for two screws important in the design of the safety filter to come loose.
- Action taken
- 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
- Status
- Terminated
- Product code
- HQF
- Quantity affected
- 200 units total
- Distribution
- Worldwide Distribution.
- Date initiated
- 2009-02-11
- Date posted
- 2010-01-20
- Date terminated
- 2012-09-07
- Location
- Adelaide, Australia
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