Lina Librata, Endometrial Ablation Device
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|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
Lina Medical Aps
Formervangen 5, Glostrup, Denmark, 2600