FDAFDA · Food and drugs·Recall number Z-2083-2013
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.
Published September 4, 2013 · Recall initiated: July 16, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Brainlab AG
- Distributor
- Worldwide Distribution - US Distribution only to AR., and the countries of Australia, Germany and Japan.
- Lot
- Part No. 43410
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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