Public recall detail

SOLTIVE™ Premium SuperPulsed Laser System

2024-09-25

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Recall Safety notice
Quick summary

Quick summary: SOLTIVE™ Premium SuperPulsed Laser System. Date: 2024-09-25.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: SOLTIVE™ Premium SuperPulsed Laser System. Date: 2024-09-25.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandGyrus Acmi, Inc
ProductSOLTIVE™ Premium SuperPulsed Laser System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76203

Affected products

ProductSOLTIVE™ Premium SuperPulsed Laser System
LotMore than 10 numbers, contact manufacturer.
ModelTFL-PLS
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSOLTIVE™ Premium SuperPulsed Laser System

Issue

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesGyrus ACMI, Inc 9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76203
Background{}
CompaniesGyrus ACMI, Inc 9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445
AudiencesHealthcare
Source updated2024-09-25

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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