Reported Jun 11, 2014 · Terminated
ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
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
Is this the product you have?
- ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
- Lot codes and dates
15 of 15 products
Products covered by this recall # Product as published 1 20818B ET SOFTWARE 5.5.5 2 20820 ET SOFTWARE UPDATE 5.0 TO 5.5 3 49905D EXACTRAC COMPLETE SYSTEM UPG 3.X TO 5.5 4 49908C EXACTRAC SOFTWARE UPGRADE 3.X TO 5.5 5 49909A EXACTRAC SOFTWARE UPGRADE 4.X TO 5.5 6 49918 ET SOFTWARE UPDATE 5.5.X TO 5.5.5 7 49919 ET SOFTWARE UPDATE 5.0.X TO 5.5.5 8 49660A ET INFRARED SOFTWARE 5.5.5 9 49961 ET DATA PREP/REVIEW SYSTEM 10 49986 ET SYSTEM UPGRADE 3.X TO 5.5 NEW VAULT 11 49987 ET SYSTEM UPGRADE 4.X TO 5.5 NEW VAULT 12 49988 ET SYSTEM UPGRADE 4.X TO 5.5 SAME VAULT 13 49989 ET SYSTEM UPGRADE 5.0 TO 5.5 NEW VAULT 14 49990 ET SYSTEM UPGRADE 5.0 TO 5.5 SAME VAULT 15 49991 ET SYSTEM UPGRADE 5.5 TO 5.5 NEW VAULT - Amount recalled
- 40 systems (worldwide)
Where it was sold
Why it was recalled
When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.
This product could cause temporary or reversible health problems — stop using it.
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