ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy proc

FDA device recall Z-1316-2015 · posted 2015-03-25 · Terminated

Recall details

Recalling firm

Brainlab AG

Reason for recall

The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT.

Action taken

BrainLab sent an FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letters dated February 16, 2015, to all affected customers. The letters included instructions for customers to: 1) Do not use any actively re-reconstructed CBCT subvolumes from the Varian TrueBeam system with the Brainlab ExacTrac 6.x CBCT Import & Alignment Software module; 2) Import exclusively original, not modified, CBCT volumes into ExacTrac to use for patient positioning; and, 3) Continue to verify any ExacTrac CBCT-based correction using the ExacTrac X-ray verification and/or an external IGRT procedure as mandatory. Brainlab provided existing potentially affected ExacTrac v.6.x CBCT Import & Alignment Software customers (with a Varian TrueBeam system) with the product notification information. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact the customer starting August 2015 to schedule the update installation. For further questions please call Customer Hotline + 49 89 99 15 68 44 or 1-800 597-5911 ( For US Customers only)

Root cause

Software in the Use Environment

Status

Terminated

Product code

IYE

Quantity affected

24 systems (US); 36 systems (Foreign)

Distribution

Worldwide Distribution - USA and to the countries of : Australia, Austria, Canada Denmark, France, Germany, Hong Kong, Japan, Russia, Singapore, South Korea and United Kingdom.

Date initiated

2015-02-16

Date posted

2015-03-25

Date terminated

2017-02-28

Location

Feldkirchen, Germany

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