Recall MonitorHealth Products
Harmonyair A-Series Surgical Lighting System
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: Harmonyair A-Series Surgical Lighting System
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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. | 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. | 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.