| Class 2 Device Recall Brainlab | |
Date Initiated by Firm | February 16, 2015 |
Date Posted | March 25, 2015 |
Recall Status1 |
Terminated 3 on February 28, 2017 |
Recall Number | Z-1316-2015 |
Recall Event ID |
70657 |
510(K)Number | K120789 |
Product Classification |
Accelerator, linear, medical - Product Code IYE
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Product | ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures.. |
Code Information |
ExacTrac versions 6.x including versions 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0. Model/Catalog Numbers: 49971, CBCT IMPORT & ALIGNMENT SOFTWARE; 20836, EXACTRAC 6.0 VARIAN CBCT LICENSE; The software may be contained in configured items: 48320, ET UPGRADE SOFTWARE 6.0 TO 6.1; 48320-99, ET UPGRADE SOFTWARE 6.0 TO 6.1 SLA; 49973B, ET DATA PREP / REVIEW SYSTEM; 49973A, ET DATA PREP / REVIEW SYSTEM; 49973, ET DATA PREP / REVIEW SYSTEM; 49998B, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT; 49998A, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT; 49998, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT; 48304, ET 6.1 DATA PREP/REVIEW SYSTEM UPG. KIT; 48302, ET DATA PREP / REVIEW SYSTEM |
Recalling Firm/ Manufacturer |
Brainlab AG Kapellenstrasse 12 Feldkirchen Germany
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For Additional Information Contact | Customer Hotline 800-5975911 |
Manufacturer 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. |
FDA Determined Cause 2 | Software in the Use Environment |
Action | 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) |
Quantity in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = IYE
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