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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description 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.
Recall Number Z-2083-2013
Classification Class II
Code Info Part No. 43410
Product Distributed Qty 6 units
Reason For Recall 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.

Event Detail

Event Id 65773
Product Type Devices
Status Ongoing
Recalling Firm Brainlab AG
City Feldkirchen
Country DE
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - US Distribution only to AR., and the countries of Australia, Germany and Japan.