Recall MonitorHarmonyAIR A-Series Surgical Lighting System AND ALYON Surgical Lighting System
· Published by Health Canada · Official notice
Details
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Alyon Surgical Lighting System | More than 10 numbers, contact manufacturer. | 0000002L |
| Alyon Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00003A2V |
| Alyon Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00003A2L |
| Alyon Surgical Lighting System | More than 10 numbers, contact manufacturer. | 003A2A1L |
| Alyon Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00003A2LT |
| Alyon Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00003L2V |
| Alyon Surgical Lighting System | More than 10 numbers, contact manufacturer. | 004A3L2V |
| Alyon Surgical Lighting System | More than 10 numbers, contact manufacturer. | 004A3L2VT |
| Alyon Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00003L2L |
| Alyon Surgical Lighting System | More than 10 numbers, contact manufacturer. | 004A3L2L |
| Alyon Surgical Lighting System | More than 10 numbers, contact manufacturer. | 1955038X |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 13A11L09F |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00013A11F |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 11041370 |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00000011L |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00011L09F |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00011L09L |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 13V11L09L |
Issue
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.