FDA Medical Device Recalls (openFDA)
Ellex Medical Pty Ltd: Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation.
- Recall number
- Z-0577-2010
- Recalling firm
- Ellex Medical Pty Ltd
- Product
- Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation.
- Status
- Terminated
- Initiated
- 2009-02-11
- Posted
- 2010-01-20
- Terminated
- 2012-09-07
- Reason
- Potential for two screws important in the design of the safety filter to come loose.
- Root cause
- Radiation Control for Health and Safety Act
- 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.
- Quantity
- 200 units total
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- Solitaire LP4532 photocoagulator.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HQF
- Firm FEI
- 3002806902
- Firm city
- Adelaide
- Firm state
- not on file
- Firm country
- Australia
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28