Safety Alert for ANGIX MOD. ADV. ANVISA registration: 80260940001.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

There is a report of a product-related adverse event: during a procedure, the operator, while making a bow movement, collided the x-ray tube against the bottom of the table, thereby triggering the anti-collision sensor. The image detector, then instead of moving away from the patient, made the opposite movement as expected and moved downward, pressing the patient's arm against the table causing a slight hematoma without further damage. The unexpected movement was quickly noticed by the operator, and the emergency button was triggered by de-energizing the equipment immediately. The event occurred due to a firmware failure (software embedded in an integrated circuit), occurring only when there is an event sequence. There is already a new version with a bug fix. A risk analysis was performed, and the severity of the risk was classified as severe, as there may be possibility of dislocations and fractures. The probability of occurrence (P1) was classified as Remote because there is a combination of factors necessary for the unexpected movement of the detector to occur. In the history of complaints, there was only this single event of involuntary movement of the detector, according to records of the last 365 days. The probability of damage (P2) was classified as improbable because the operator has the entire visual field of the equipment and can interrupt the event immediately when observed. For example, the operator can turn off the system via the emergency button on the console. In addition to this feature, another existing mitigation is that the movement of the detector shaft is limited to 10 mm when the emergency button is actuated. However, because a situation classified as RMR was detected (RMR - necessary risk mitigation), this field action was required due to this adverse post-marketing event.