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TGA Action ID	RC-2026-RN-00264-1
Type of Product	Medical Device
Product Name/Description	Chromophare surgical lights with Soffit Rings Part Number: CH00000001 GTIN: 07613327296167
ARTG Number	231776
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Certain lots of the soffit ring may not adequately support the weight of the ceiling cover. As a result, the cover may shift or slide down the ceiling tube. Movement of the ceiling cover can expose the area above the ceiling, which may allow particles, such as dust, debris, residue, or other contaminants, to enter the sterile field.
Instructions for Customers/Users	Customers should: 1. Immediately review the Customer Letter 2. Return the Response Form to Stryker, confirming agreement for Stryker to perform inspection and replacement of affected components. 3. Upon receipt of the response form a Stryker representative will help coordinate a service visit to complete an inspection and replacement of all affected components.
Action Commencement Date	10/04/2026
Responsible Entity	Stryker Australia Pty Ltd
Contact Information	postmarketssp@stryker.com or 0437 112 648 - Avalon Grygorcewicz .