Reported Sep 4, 2013 · Terminated

BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll…

Brainlab AG

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Brainlab AG · Kapellenstrasse 12 · Feldkirchen · N/A

Is this the product you have?

  • 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'shead and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures
Lot codes and dates
  • Part No. 43410
Amount recalled
6 units

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 13, 2017 · Data as of Sep 19, 5:31 PM UTC

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