ExacTrac 6.0.x recallZ-2440-2015 · Brainlab AG · initiated Aug 5, 2015

Why it was recalled

ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification.

FDA root cause category: Software in the Use Environment

What the company is doing

Brainlab intends to distribute the Field Safety Notice / Product Notification letter CAPA-20150713-001446, dated July 20, 2015, to the customers. The letter provides instructions for the user on how to address this issue, and to avoid a patient and treatment target position potentially different than intended due to this issue. The Field Safety Notice / Product Notification letter states that as generally required, always verify that the correct DRRs for the current patient are displayed in ExacTrac and an accurate fusion to the X-Ray images is possible for patient positioning. In case incorrect DRRs are displayed, exit and re-start the ExacTrac software. To minimize the probability of this issue occurring for the affected ExacTrac versions: -Reduce the amount of contours exported to ExacTrac as far as possible. -Avoid exporting large contours, such as couch top models, to ExacTrac. -After every (re-)start of the ExacTrac application on any workstation, always first load a phantom plan not containing contours. The Field Safety Notice / Product Notification letter states that as a general reminder the user should always follow the instructions and warnings as described in the user guide. In the context of this notification please specifically consider the safety notes relevant for X-ray correction and verification: -The image overlay functions must be used to verify fusion accuracy in both image views, especially if the images contain a series of similar structures such as vertebrae. -Do not perform patient treatment unless accurate image fusion is possible. -Large correction shifts (e.g. greater than 10 mm) may indicate incorrect automatic fusion. In such cases, verify the correction shift a second time. Brainlab Corrective Action: 1. Existing potentially affected ExacTrac 6.0.x customers receive the product notification information. 2. Brainlab will provide a software revision (ExacTrac v. 6.0.6) with this issue solved to affe

Recall details

Recall number

Z-2440-2015

Recall class

Class II

Status

Terminated

Initiated by the company

Aug 5, 2015

Posted by the FDA

Aug 21, 2015

Recalling firm

Brainlab AG

Quantity

361 systems

Product code

IYE

FDA submissions

K120789

Distribution

Worldwide Distribution - USA including the states of AL, AZ, AK, CA CO, CT, FL, GA, ID, IL IN, KY, LA, MD, MA, MI, MN, NE, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, and WI; and, the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Netherlands, Panama, Qatar, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.

Product description

ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.

Other devices under the same FDA submission

2 devices cleared under K120789 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Exactrac 6.2

  Brainlab SE · Accelerator, Linear, Medical
  1 recall6 reports
• Exactrac 6.5

  Brainlab SE · Accelerator, Linear, Medical
  1 recall0 reports