Harmonyair A-Series Surgical Lighting System
Brand(s)
Last updated
Summary
Product
Harmonyair A-Series 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 |
|---|---|---|
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00013A11LT |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00013A11L |
| 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. | 11008835 |
| 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. | 00000011L |
| Harmonyair A-Series Surgical Lighting System | More than 10 numbers, contact manufacturer. | 00013H11L |
| 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. | 13A11L09L |
| 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 paint from the lighting system's light head may begin to peel or chip over time as a result of routine cleaning procedures. While Steris has not received any reports of paint falling from a lighting system during use, if paint particles were to enter the sterile field or fall onto a patient, this could disrupt the procedure resulting in a procedure delay and/or may present a risk of patient infection.
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-81917
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