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Brainlab AG recalls BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (ro
Recalled September 4, 2013 · FDA recall Z-2083-2013 · Brainlab AG
Hazard
The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap. · FDA Class II
Units
6 units
Sold at
Worldwide Distribution - US Distribution only to AR., and the countries of Australia, Germany and Japan.
Description
The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap.
Product
BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.
Manufacturer(s)
Brainlab AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →