ExacTrac 6.x. is software used to place patients at an… recallZ-1582-2015 · Brainlab AG · initiated Mar 6, 2015

Why it was recalled

ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees.

FDA root cause category: Software in the Use Environment

What the company is doing

FIELD SAFETY / PRODUCT NOTIFICATION letters dated March 6, 2015 were sent to all customers of record. The letters included instructions for customers to: 1) With immediate effect, always make sure the couch is at exactly 0.0 degrees (displayed on the Varian monitor) when acquiring a CBCT set to import into the ExacTrac software; 2) For Varian systems providing an option to prevent a CBCT acquisition for couch angles other than 0.0 degrees, Brainlab recommends selecting that option for use in combination with ExacTrac; and, 3) Continue to verify any ExacTrac CBCT based correction using the ExacTrac X-ray verification and/or an external IGRT procedure as mandatory. The letters further advised that Brainlab will be taking the following actions: 1. Brainlab provides existing potentially affected ExacTrac v.6.x CBCT Import & Alignment Software customers (with a Varian C-Series linac) with this product notification information; and, 2. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact the customers starting August 2015 to schedule the update installation. Customers with questions about this issue were advised to contact Brainlab at 800-597-5911 or via e-mail by writing at [email protected].

Recall details

Recall number

Z-1582-2015

Recall class

Class II

Status

Terminated

Initiated by the company

Mar 6, 2015

Posted by the FDA

May 6, 2015

Recalling firm

Brainlab AG

Quantity

25 systems (US only); 53 systems (Foreign)

Product code

IYH

FDA submissions

K120789

Distribution

*** US: Nationwide; *** FOREIGN: Austria, China, Denmark, France, Germany, Hong Kong, Japan, Netherlands, Qatar, Russian Federation, South Korea, Switzerland

Product description

ExacTrac 6.x. is software 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