Reported May 13, 2015 · Terminated
ExacTrac 6.x. is software 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 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
- Lot codes and dates
- Software Versions
ExacTrac v. 6.x (v. 6.0.06.0.16.0.26.0.36.0.46.0.5and v. 6.1.0)
- Model/Catalog Numbers
49971CBCT IMPORT & ALIGNMENT SOFTWARE20836EXACTRAC 6.0 VARIAN CBCT LICENSE48320ET UPGRADE SOFTWARE 6.0 TO 6.148320-99ET UPGRADE SOFTWARE 6.0 TO 6.1 SLA49973BET DATA PREP / REVIEW SYSTEM49973AET DATA PREP / REVIEW SYSTEM49973ET DATA PREP / REVIEW SYSTEM49998BET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT49998AET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT49998ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT48304ET 6.1 DATA PREP/REVIEW SYSTEM UPG. KIT48302ET DATA PREP / REVIEW SYSTEM
- Software Versions
- Amount recalled
- 25 systems (US only); 53 systems (Foreign)
Where it was sold
- Nationwide
Why it was recalled
ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees.
This product could cause temporary or reversible health problems — stop using it.
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