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Soltive™ premium superpulsed tf laser system
Official notice
29 Feb 2024
Last checked
29 Feb 2024
An official Health Canada notice concerns Soltive™ premium superpulsed tf laser system. As part of Olympus' post market surveillance of SOLTIVE™ laser use, including a review of customer complaints and adverse events, we have become aware that some clinicians are defaulting to the preset laser values for all clinical procedures when that is not consistent with the instructions for use. Olympus is reminding users that preset treatment parameters may not be appropriate for all patients and are guidelines only. Olympus is sending this reminder after reviewing twenty-eight (28) complaints reported between 2021 to 2023 related to ureteral stone procedures, that described serious injuries. Recall start date: February 5, 2024 Published 2024-02-29.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75158
Official notice
2024-02-29
The hazard
The hazard
As part of Olympus' post market surveillance of SOLTIVE™ laser use, including a review of customer complaints and adverse events, we have become aware that some clinicians are defaulting to the preset laser values for all clinical procedures when that is not consistent with the instructions for use. Olympus is reminding users that preset treatment parameters may not be appropriate for all patients and are guidelines only. Olympus is sending this reminder after reviewing twenty-eight (28) complaints reported between 2021 to 2023 related to ureteral stone procedures, that described serious injuries. Recall start date: February 5, 2024
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Affected area 1
Company & contacts
Company & contacts
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Brand: Gyrus Acmi, Soltive™ Premium Superpulsed Tf Laser System.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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