Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BRAINLAB Recalled by Brainlab AG Due to The Frameless SRS QA Target Pointer - Pointer...

Date: July 16, 2013
Company: Brainlab AG
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Brainlab AG directly.

Affected Products

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.

Quantity: 6 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 1 state: AR

Affected (1 state)Not affected

About Brainlab AG

Brainlab AG has 39 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report