| TGA Action ID |
RC-2026-RN-00312-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Harmony AIR A-Series & ALYON Surgical Lighting System
HarmonyAIR A-Series Lighting System light heads supplied between 13 July 2023 and 18 March 2026
HarmonyAIR A-Series Surgical Lighting Systems and ALYON Surgical Lighting Systems supplied between 2 December 2024 and 7 April 2026 |
| ARTG Number |
148834 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
STERIS has identified 2 problems affecting HarmonyAIR A-Series Surgical Lighting System and one problem affecting the ALYON Surgical Lighting System, each associated with a specific distribution date range.
The first problem involves potential paint delamination (chipping/peeling) on Harmony AIR A-Series Lighting System’s light heads. This problem affects certain light heads distributed between July 13, 2023 and March 18, 2026.
The second problem relates to the plus and minus buttons (+/-) used to control light intensity on the light heads of the HarmonyAIR A-Series Surgical Lighting Systems and ALYON Surgical Lighting System. These buttons may detach on certain light heads and handles distributed between December 2, 2024 and April 7, 2026. |
| Instructions for Customers/Users |
All affected Customers will be contacted by a STERIS Service Technician to arrange an onsite inspection of their lighting system(s) to perform the correction as soon as possible.
1. For the paint problem, each affected lighting system will undergo a full visual inspection for any signs of paint delamination; as needed a service kit will be installed to prevent paint chipping from occurring or if deemed necessary replaced.
2. For the button problem, each affected lighting system will undergo inspection for any signs of potential separation from the light head and handle. Buttons failing this inspection will be replaced.
Users can continue to use their lighting system(s) prior to completion of the correction. Users are reminded to ensure no excess fluids remain on light head during or after cleaning, per the Operator Manual. Should paint chipping be observed or detachment of the plus/minus (+/-) buttons occur prior to the correction being completed, users should immediately contact their local STERIS representative.
This action has been finalised on 21/9/2026. |
| Action Commencement Date |
19/05/2026 |
| Responsible Entity |
|
| Contact Information |
1300 211 422 - Steris Australia |