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Single use mechanical lithotriptor v

Official notice

31 Dec 2024

Last checked

31 Dec 2024

High riskHealth Canada

An official Health Canada notice concerns Single use mechanical lithotriptor v. Olympus has identified an increase in complaints for BML-V442QR-30. The complaint data analysis found that distal tip tearing of the Mechanical Lithotriptor V had increased beginning with the production of lot 33k. Olympus has identified 296 complaints for the BML-V442QR-30 globally between June 1, 2021, through July 31, 2024. There were 169 reportable malfunctions, and there was one report of a serious injury in relation to this issue. Recall start date: December 18, 2024 Published 2024-12-31.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76779

Official notice

2024-12-31

The hazard

Olympus has identified an increase in complaints for BML-V442QR-30. The complaint data analysis found that distal tip tearing of the Mechanical Lithotriptor V had increased beginning with the production of lot 33k. Olympus has identified 296 complaints for the BML-V442QR-30 globally between June 1, 2021, through July 31, 2024. There were 169 reportable malfunctions, and there was one report of a serious injury in relation to this issue. Recall start date: December 18, 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

76779

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Affected products

Product 1

Affected products - Single Use Mechanical Lithotriptor V, Lot or serial number - 3ZK 3XK 3YK 33K-39K 41K-44K, Model or catalogue number - BML-V442QR-30

Risk / hazard

Olympus has identified an increase in complaints for BML-V442QR-30. The complaint data analysis found that distal tip tearing of the Mechanical Lithotriptor V had increased beginning with the production of lot 33k. Olympus has identified 296 complaints for the BML-V442QR-30 globally between June 1, 2021, through July 31, 2024. There were 169 reportable malfunctions, and there was one report of a serious injury in relation to this issue. Recall start date: December 18, 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: Olympus Medical, Single Use Mechanical Lithotriptor V.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

high

Recall details

Recall number

76779

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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