The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning Patient Data Manager and Origin Data Management manufactured by Brainlab. The affected devices are identified as follows:
According to the alert, when users actively deselect a fused reference dataset in Content Manager (the default setting is "selected"), a contained Point, Object or Trajectory may appear shifted and/or distorted in the subsequently used Brainlab navigation or planning software.
If a reference dataset is deselected and the error occurs, the magnitude of shift or distortion varies, depending on the differences between the two datasets. Therefore, for some cases, the shift or distortion will be clearly visible when the plan is used in a Brainlab planning or navigation system. However, a shift could also be non-obvious. If a shift or distortion occurred and was not detected during review of the data, the deviation of the information displayed in the Brainlab planning or navigation software could mislead the user regarding clinical decisions. This could ultimately lead to ineffective treatment, serious injury or even death of the patient.
For details, please refer to the MHRA website:
https://www.gov.uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-21-to-25-september-2015
If you are in possession of the affected products, please contact your supplier for necessary actions
Posted on 29 September 2015