Health product recall

Lina Librata, Endometrial Ablation Device

Brand(s)
Last updated

Summary

Product
Lina Librata, Endometrial Ablation Device
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Lina Librata, Endometrial Ablation Device (01)05708265013487 LIB-1

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Obstetrics and gynaecology
Companies

Lina Medical Aps

Formervangen 5, Glostrup, Denmark, 2600

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72661