ExacTrac is intended to be used to place patients at an recall
ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic…
Why was ExacTrac is intended to be used to place patients at an recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
ExacTrac Version 6.0.4; Model/Catalog Numbers: 1) 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE; 2) 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE; 3) 20835C EXACTRAC 6.0 IR MONITORING SOFTWARE; 4) 20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE; 5) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR); 6) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR); 7) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR); 8) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED; 9) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC; 10) 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4; 11) 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4; 12) 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R; 13) 49973B ET DATA PREP / REVIEW SYSTEM; 14) 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY; 15) 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED; 16) 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT
- Product
- ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic…
- Recalling firm
- Brainlab AG
- Quantity
- 15 systems
- Distribution
- Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia.
- Recall date
- August 13, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)