Z-0578-2010

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

Name: Z-0578-2010 Motorised Safety Filter, Wild; Model number 6339590. Intended for photocoagulation
Creator: Ellex Medical Pty Ltd
Published: 2009-02-11
License: https://open.fda.gov/license/

Ellex Medical Pty Ltd / initiated 2009-02-11 / Terminated / root cause: design

FDA source

Ellex Medical Pty Ltd began a recall of Motorised Safety Filter, Wild; Model number 6339590. Intended for photocoagulation on 2009-02-11. The reason FDA records is "Potential for two screws important in the design of the safety filter to come loose". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0578-2010
Status: Terminated
Initiated: 2009-02-11
Posted: 2010-01-20
Terminated: 2012-09-07
Recalling firm: Ellex Medical Pty Ltd
Product: Motorised Safety Filter, Wild; Model number 6339590. Intended for photocoagulation.
Product code: HQF Laser, Ophthalmic
Reason for recall: Potential for two screws important in the design of the safety filter to come loose.
Root cause tag: design
FDA 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 in commerce: 200 units total
Distribution: Worldwide Distribution.
Product codes and lots: Solitaire LP4532 photocoagulator.

Product code HQF

The FDA recall record names no cleared device, and no clearance has been matched to it.

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)