SOLTIVE Laser System Recall
Summary
Health Canada has issued a Type II recall for the SOLTIVE Premium SuperPulsed Laser System due to a defect in the 24V power supply causing sudden power loss. Affected healthcare providers should contact the manufacturer for service coordination.
What changed
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, which has resulted in 98 reported incidents of sudden power loss or failure to power on. The affected product model is TFL-PLS, with numerous lot or serial numbers requiring manufacturer contact for identification.
Healthcare providers in possession of the affected laser system should contact Olympus representatives to coordinate service and potential upgrades. The recall highlights the importance of robust quality control in medical device manufacturing and the need for prompt action to address performance issues that could impact patient care or device functionality. While no specific compliance deadline is stated, immediate contact with the manufacturer is advised.
What to do next
- Contact the manufacturer (Olympus/Gyrus Acmi, Inc.) to coordinate service for affected SOLTIVE Premium SuperPulsed Laser System units.
- Identify affected units by lot or serial number, or by contacting the manufacturer.
Source document (simplified)
Health product recall
SOLTIVE Premium SuperPulsed Laser System
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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