Recall Z-1316-2015 ยท IYE Accelerator, Linear, Medical
Brainlab AG
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
| Date | Mar 25, 2015 (initiated Feb 16, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software in the Use Environment |
| Action | BrainLab sent an FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letters dated February 16, 2015, to all affected customers. The letters included instructions for customers to: 1) Do not use any actively re-reconstructed CBCT subvolumes from the Varian TrueBeam system with the Brainlab ExacTrac 6.x CBCT Import & Alignment Software module; 2) Import exclusively original, not modified, CBCT volumes into ExacTrac to use for patient positioning; and, 3) Continue to verify any ExacTrac CBCT-based correction using the ExacTrac X-ray verification and/or an external IGRT procedure as mandatory. Brainlab |
| Quantity | 24 systems (US); 36 systems (Foreign) |
| Distribution | Worldwide Distribution - USA and to the countries of : Australia, Austria, Canada Denmark, France, Germany, Hong Kong, Japan, Russia, Singapore, South Korea and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120789 | EXACTRAC X-RAY X-RAY Brainlab AG, Aug 14, 2012 |