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No image published for this recall

Soltive laser system

Official notice

12 Jul 2024

Last checked

12 Jul 2024

Medium riskHealth Canada

An official Health Canada notice concerns Soltive laser system. Olympus investigated complaints received where customers reported difficulties in pairing the wireless footswitch with the Soltive laser, resulting in delays in surgical procedures or prolonged surgery. In an effort to mitigate any immediate and potential risk to patient health, Olympus is requiring Soltive laser users to have an Olympus wired footswitch (part number TFL-AFSW) available for immediate use as a backup in the event a wireless footswitch does not pair with the Soltive laser. Recall start date: June 28, 2024 Published 2024-07-12.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75813

Official notice

2024-07-12

The hazard

Olympus investigated complaints received where customers reported difficulties in pairing the wireless footswitch with the Soltive laser, resulting in delays in surgical procedures or prolonged surgery. In an effort to mitigate any immediate and potential risk to patient health, Olympus is requiring Soltive laser users to have an Olympus wired footswitch (part number TFL-AFSW) available for immediate use as a backup in the event a wireless footswitch does not pair with the Soltive laser. Recall start date: June 28, 2024

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.

Recall Numbers

75813

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Affected products

Product 1

Affected products - Soltive Premium Superpulsed Laser System, Lot or serial number - All lots., Model or catalogue number - TFL-PLS

Product 2

Affected products - Soltive Wired Footswitch, Lot or serial number - All lots., Model or catalogue number - TFL-AFSW

Product 3

Affected products - Soltive Wireless Footswitch, Lot or serial number - All lots., Model or catalogue number - TFL-AFSWL

Risk / hazard

Olympus investigated complaints received where customers reported difficulties in pairing the wireless footswitch with the Soltive laser, resulting in delays in surgical procedures or prolonged surgery. In an effort to mitigate any immediate and potential risk to patient health, Olympus is requiring Soltive laser users to have an Olympus wired footswitch (part number TFL-AFSW) available for immediate use as a backup in the event a wireless footswitch does not pair with the Soltive laser. Recall start date: June 28, 2024

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Gyrus Acmi, Soltive Laser System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75813

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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