CanadaThe HarmonyAIR A-Series Surgical Lighting System and ALYON (Alyon) Surgical Lighting System, identified by the listed model/catalogue numbers and serial/lot numbers (contact the manufacturer for specific serials), are affected. Steris identified that the plus/minus (+/−) buttons controlling light intensity on the light heads may detach and, if they enter the sterile field during a procedure, could disrupt the procedure and cause a delay. Users should ensure no excess fluids remain on the light head during or after cleaning per the operator manual, may continue to use the systems prior to completion of the correction, and should contact their local Steris representative or the manufacturer for more information.
What's being recalled
Companies: Steris Corporation, 2720 Gunter Park East, Montgomery, Alabama, United States, 36109.
How to identify it
Affected products: Alyon Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 0000002L
Affected products: Alyon Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00003A2V
Affected products: Alyon Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00003A2L
Affected products: Alyon Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 003A2A1L
Affected products: Alyon Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00003A2LT
Affected products: Alyon Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00003L2V
Affected products: Alyon Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 004A3L2V
Affected products: Alyon Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 004A3L2VT
Affected products: Alyon Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00003L2L
Affected products: Alyon Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 004A3L2L
Affected products: Alyon Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 1955038X
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 13A11L09F
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00013A11F
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 11041370
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00000011L
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00011L09F
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00011L09L
Affected products: Harmonyair A-Series Surgical Lighting System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 13V11L09L
The hazard
Steris identified through customer complaints that on Harmonyair A-Series Lighting System and Alyon Surgical Lighting System the plus/minus (+/-) buttons that control light intensity on the light heads may detach. If detachment occurs during a patient procedure, the buttons could enter the sterile field and disrupt the procedure resulting in a procedure delay. 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 detachment of the plus/minus (+/-) buttons occur prior to the correction being completed, users should immediately contact their local Steris representative.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States