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Soltive™ premium superpulsed laser system
Official notice
25 Sept 2024
Last checked
25 Sept 2024
An official Health Canada notice concerns Soltive™ premium superpulsed laser system. Olympus received a complaint regarding the SOLTIVE™ Laser System preset laser settings. The term "bladder stone" was incorrectly translated in both Spanish and Portuguese to "kidney stone" (cálculo renal) on the systems' graphical user interface (GUI). As a result of the incorrect Spanish and Portuguese translation from "bladder stone" to "kidney stone" on the GUI, there is a potential to deliver an incorrect or unintended amount of energy to the patient's anatomy. This issue is specific to the preset laser settings and does not affect users who are not utilizing the preset option. Recall start date: September 12, 2024 Published 2024-09-25.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76203
Official notice
2024-09-25
The hazard
The hazard
Olympus received a complaint regarding the SOLTIVE™ Laser System preset laser settings. The term "bladder stone" was incorrectly translated in both Spanish and Portuguese to "kidney stone" (cálculo renal) on the systems' graphical user interface (GUI). As a result of the incorrect Spanish and Portuguese translation from "bladder stone" to "kidney stone" on the GUI, there is a potential to deliver an incorrect or unintended amount of energy to the patient's anatomy. This issue is specific to the preset laser settings and does not affect users who are not utilizing the preset option. Recall start date: September 12, 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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Affected products
Product 1
Risk / hazard
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.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Gyrus Acmi, Soltive™ Premium Superpulsed Laser System.
Source & status
Source & status
Source
Tier
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Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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