SOLTIVE Premium SuperPulsed Laser System Recall
Summary
Health Canada has issued a Type II recall for the SOLTIVE Premium SuperPulsed Laser System manufactured by Gyrus Acmi, Inc. The recall is due to a defect in the 24V power supply causing sudden power loss or failure to power on. Affected customers will be contacted by Olympus representatives to schedule service.
What changed
Health Canada has issued a Type II recall for the SOLTIVE Premium SuperPulsed Laser System (Model TFL-PLS) due to a defect in the 24V power supply, which has resulted in 98 complaints of sudden power loss or failure to power on. The manufacturer, Gyrus Acmi, Inc., will be coordinating service for affected units with customers.
Healthcare providers in possession of the affected laser system should contact the manufacturer for additional information and to schedule service. This recall highlights the importance of robust quality control in medical device manufacturing and the need for prompt action in addressing performance issues to ensure patient safety and device reliability.
What to do next
- Contact manufacturer for service of affected SOLTIVE Premium SuperPulsed Laser System units.
- Document service arrangements for affected units.
Source document (simplified)
Health product recall
SOLTIVE Premium SuperPulsed Laser System (French translation pending)
Brand(s)
Last updated
2026-03-13
Summary
Product SOLTIVE Premium SuperPulsed Laser 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 |
| --- | --- | --- |
| SOLTIVE Premium SuperPulsed Laser System | More than 10 numbers, contact manufacturer. | TFL-PLS |
Issue
Olympus received 98 complaints of sudden power loss or failure to power on in SOLTIVE superpulsed Laser System due to a defect in the 24V power supply. Olympus representatives will begin contacting customers to coordinate the service of affected unit(s) upon establishment of position in the upgrade queue.
Additional information
Details
Original published date:
2026-03-13
Alert / recall type Health product recall Category Health products - Medical devices - General hospital and personal use Companies Gyrus Acmi, Inc
9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445
Published by Health Canada Audience Healthcare Recall class Type II Recall date
2026-02-27
Identification number RA-81733
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