Reported Aug 13, 2014 · Terminated
ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical…
Brainlab AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Brainlab AG · Kapellenstrasse 12 · Feldkirchen, N/A · N/A
Is this the product you have?
- ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
- Lot codes and dates
16 of 16 products
Products covered by this recall # Product as published 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 - Amount recalled
- 15 systems
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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