Reported Apr 1, 2015 · Terminated
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy…
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 versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
- Lot codes and dates
- ExacTrac versions 6.x including versions 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0
- Model/Catalog Numbers
49971CBCT IMPORT & ALIGNMENT SOFTWARE20836EXACTRAC 6.0 VARIAN CBCT LICENSEThe software
- may be contained in configured items
48320ET 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
- Amount recalled
- 24 systems (US); 36 systems (Foreign)
Why it was recalled
The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT.
This product could cause temporary or reversible health problems — stop using it.
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