Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning all 2nd Edition O-arm 1000 Imaging System. The affected devices are identified as follow:
The manufacturer released software version 3.1.7. The change is in response to customer complaints and addresses several known software anomalies. The software anomalies were reported to affect the following system functionalities:
According to the manufacturer, over the last six years, five complaints led to cancelled procedures after the patient was under anaesthesia requiring additional surgery. The field action is being initiated to address the issues relating to these complaints.
The local supplier will contact affected users to schedule completion of the software install. The affected users may choose to continue to use their 2nd Edition O-arm 1000 Imaging System at their clinical discretion in the meantime, but they should be aware of the issues described above, which may result in a delayed surgery, patient exposure to non-navigated surgery, patient exposure to additional surgery or unused X-ray dose.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 10 September 2018