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Lina librata, endometrial ablation device
Official notice
7 Feb 2023
Last checked
7 Feb 2023
An official Health Canada notice concerns Lina librata, endometrial ablation device. During the investigation process of customer complaints, Lina has become aware of a safety issue in relation to the use of an obsolete version of an accompanying document. The use of an obsolete customer quick reference guide resulted in the incorrect interpretation of the device alarm pattern which led to inadequate actions performed and consequently patient injury. This recall process only applies to the customer quick reference guide. Recall start date: December 14, 2022 Published 2023-02-07.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72661
Official notice
2023-02-07
The hazard
The hazard
During the investigation process of customer complaints, Lina has become aware of a safety issue in relation to the use of an obsolete version of an accompanying document. The use of an obsolete customer quick reference guide resulted in the incorrect interpretation of the device alarm pattern which led to inadequate actions performed and consequently patient injury. This recall process only applies to the customer quick reference guide. Recall start date: December 14, 2022
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.
Recall Numbers
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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
Manufacturer
Phone
Brand: Lina Medical Aps, Lina Librata Endometrial Ablation Device.
Source & status
Source & status
Source
Tier
Category
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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