Brainlab AG: Medical Device Recall in 2013 - (Recall #: Z-2083-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 16, 2013

Date Posted: September 4, 2013

Recall Number: Z-2083-2013

Event ID: 65773

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.

Status: Terminated

Product Quantity: 6 units

Code Information:

Part No. 43410

Distribution Pattern:

Worldwide Distribution - US Distribution only to AR., and the countries of Australia, Germany and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated