Recall Z-1316-2015— Brainlab AG
Class II · Terminated
Class II FDA medical device recall by Brainlab AG, initiated 2015-02-16, terminated 2017-02-28. It names one FDA 510(k) clearance: K120789. Product: ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures... 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..
- Recalling firm
- Brainlab AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-16
- Terminated
- 2017-02-28
- Firm location
- Feldkirchen, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.