Safety Alerts

The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Siemens Healthineers SOMATOM X.cite, SOMATOM X.ceed, SOMATOM go.Up, SOMATOM go.Open Pro, SOMATOM go.All, SOMATOM go.TOP, SOMATOM go.Sim, SOMATOM go.Now or NAEOTOM Alpha. [HKMD No.: 180018, 180127, 200362, 210017, 210298, 220207, 210410].

According to the MHRA, the manufacturer is informing users about a potential problem which may occur in the myNeedle Guide CT Intervention application:

In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels“head”, “center”, and “feet” in the axial thick slice segments are erroneously swapped in the following two cases:

• if the Recon parameter“Image order”is changed by the user from the default setting“Head to Feet”to“Feet to Head”, or
• if the Recon parameter“Mirroring”is changed by the user from the default setting“none”to any other value, this influences the parameter “Image order”, which is switched from the default setting “Head to Feet” to “Feet to Head” so that above-mentioned condition applies.

As a consequence, the head segment might mistakenly be labeled as “feet” and vice versa. If the wrong orientation labels are used by the interventionalist to determine the direction in which the needle has to be tilted (towards the head or towards the feet), this might result in the wrong placement and angulation of the needle, leading to potential unwanted damage to sensitive anatomical structures.

In addition, if the “move to selected axial slice position” functionality is used to position the patient table for the next scan, and the user’s selection of segment is based on the wrong orientation label, this could lead to a scan being performed at the wrong position.

For further information, please visit https://mhra-gov.filecamp.com/s/FaUQJNvkz9XM8aH4/d

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 17 Jan 2023