ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical

FDA device recall Z-2146-2014 · posted 2014-08-04 · Terminated

Recall details

Recalling firm

Brainlab AG

Reason for recall

When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.

Action taken

Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated June 24, 2014, to all affected customers. The letter included instructions for customers to: 1) Avoid using plans with multiple isocenters in ExacTrac 6.0.4 whenever possible, and 2) If plans with multiple isocenters cannot be avoided and such a plan is used in ExacTrac v.6.0.4, then always select "Yes" in the dialog displayed to "keep the previous correction shift" when switching between isocenters and always verify all final treatment positions. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact you to schedule the update within the next 6 months. Customers with questions can contact Brainlab at 800-597-5911 or via e-mail at us.support@brainlab.com.

Root cause

Software design

Status

Terminated

Product code

IYE

Quantity affected

15 systems

Distribution

Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia.

Date initiated

2014-06-24

Date posted

2014-08-04

Date terminated

2017-04-24

Location

Feldkirchen, Germany

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