Health product recall

HarmonyAIR A-Series Surgical Lighting System AND ALYON Surgical Lighting System

Last updated

Summary

Product
HarmonyAIR A-Series Surgical Lighting System AND ALYON Surgical Lighting System
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected 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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies

Steris Corporation

2720 Gunter Park East, Montgomery, Alabama, United States, 36109

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82097

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