Medical device manufacturer, Meditech Kft, has issued a medical device safety alert concerning its Meditech ABPM-05 ambulatory blood pressure monitor [Serial numbers: 2021/527101, 2021/527152, 2021/527153, 2021/527154, 2021/527155, 2021/527156, 2021/527157; Devices shipped between 2 Sep 2021 and 13 Oct 2021].
The manufacturer is informing users that products with indicated serial numbers were delivered to distributors with a changed motor pump component after submission of change request documentation but prior to approval by Notified Body so they are not identical with approved technical documentation. According to the manufacturer, this failure should not impact users or patients in any way.
The manufacturer advises affected user to identify, discontinue use, and return all affected product.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 1 Dec 2021