U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Accelerator, linear, medical - Product Code IYE
원인
Potentially incorrect positioning when using implanted marker detection with brainlab exactrac vero 3.5.
조치
A FIELD SAFETY NOTICE / PRODUCT NOTIFICATION was sent to customers on May 4, 2016 and distributed via email. An active reply by the consignees will be followed, if necessary via further different communication media.
As of now for new installations
- the Product Notification letter is handed over to the customer during installation (before clinical use) by the according Brainlab Service representative,
- a signature is required by the customer that the contained User Corrective Action will be implemented before clinical use by the facility (to be adhered to by the users).
Brainlab Instructions and actions required to be performed by the customer are described below.
1. For Positioning and Verification, carefully review plausibility of implant marker fusions resulting in rotation angles of more than 10¿.
If in doubt consider the following options before proceeding:
- Deselect one or several markers defined in the CT data set, if you suspect these markers to have migrated
- Apply bony fusion instead of marker based fusion
- Apply ConeBeam CT correction and verification instead of marker based fusion
- Acquire a new CT scan and repeat treatment planning and definition of implanted marker positions based on the new CT data.
For further details regarding the suggested proceedings, please consult the according Clinical User Guide.
2. For Dynamic Tracking continue to follow the instructions of the Clinical User Guide regarding the review of the correlation model based on implanted marker detections. Specifically:
- Examine the correctness of localization of markers and targets in the X-ray sequence.
- Verify the consistency of the Target Detection Curve and/or Correlation Model Curve. Irregularities of the curves are an indication for incorrect implanted marker detection. In this case please consider the options described in 1. before proceeding.
If the customers require further clarification, they should contact their local Brainlab Customer
Potentially affected is ExacTrac Vero version 3.5 (including all subversions). Serial numbers/lot numbers are not applicable for a software version. Model/catalogue numbers: 20892 EXACTRAC VERO SOFTWARE 3.5 20892A EXACTRAC VERO SOFTWARE 3.5.1 20892B EXACTRAC VERO SOFTWARE 3.5.2 20892C EXACTRAC VERO SOFTWARE 3.5.3 20893 VERO INFRARED POSITIONING/MONITORING SW 46213 EXACTRAC VERO SW UPDATE 3.5 TO 3.5.1 46214 EXACTRAC VERO UPGRADE KIT 3.2 to 3.5 FOC 46215 EXACTRAC VERO UPGRADE KIT 3.1 TO 3.5 FOC 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46228 EXACTRAC VERO 3.5 ROW 46238 EXACTRAC VERO 3.5 JAPAN