ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
Reported: April 1, 2015 Initiated: February 16, 2015 #Z-1316-2015
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.
Details
- Recalling Firm
- Brainlab AG
- Units Affected
- 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.
- Location
- Feldkirchen
Frequently Asked Questions
What product was recalled? ▼
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures... Recalled by Brainlab AG. Units affected: 24 systems (US); 36 systems (Foreign).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 1, 2015. Severity: Moderate. Recall number: Z-1316-2015.
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