Devices

Device Recall ExacTrac Robotics

Model / Serial
bundle #06-69448-49700, tilt module #3520-05-011-49720; bundle #06-69445-49700, tilt module #3520-05-006-49720; bundle #06-78573-49700, tilt module #3520-05-017-49720; bundle #06-69573-49700, tilt module #3520-05-002-49720; bundle #06-78149-49700, tilt module #3520-05-015-49720; bundle #06-66427-49700, tilt module #3520-05-013-49720; bundle #06-62416-49700, tilt module #3520-05-008-49720; tilt module #3520-05-018-49720; bundle #06-77290-49700, tilt module #3520-05-019-49720; bundle #06-77669-49700, tilt module #3520-05-020-49720; bundle #06-78440-49700, tilt module #3520-05-014-49720; bundle #06-74601-49700, tilt module #3520-05-010-49720; bundle #06-64377-49700, tilt module #7520-05-005-49720;
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, including the states of California, Colorado, Florida, Illinois, Maryland, Michigan, Missouri, New Hampshire, New York, North Carolina, Ohio, Pennsylvania, Tennessee and Texas
Product Description
ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, for installation on the Varian Exact Couch, a component of the Novalis Shaped Beam Surgery System; a table tilt device - powered radiation therapy patient support assembly; BrainLab AG, Ammerthalstrasse 8, 85551 Heimstetten, Germany
Manufacturer
Brainlab AG
1 Event
- Recall of Device Recall ExacTrac Robotics

Manufacturer

Brainlab AG

Manufacturer Address
Brainlab AG, Ammerthalstrasse 8, Kirchheim B. Muenchen Germany
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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