FDAFDA · Food and drugs·Recall number Z-1513-2014
ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49973B ET DATA PREP / REVIEW SYSTEM 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED
Published May 7, 2014 · Recall initiated: February 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point. As a result, there is a possibility that the radiation treatment dose may be delivered to the unintended target position.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Brainlab AG
- Distributor
- Worldwide Distribution -- USA, including the states of CA, IN, LA, MA, OH, TX, and WI, and the countries of Australia, China, France, Germany, Japan, Netherlands, and the United Kingdom.
- Lot
- ExacTrac version v.6.0.3.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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