Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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, lo

U.S. FDA — Device Enforcement · Germany · 2013-07-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2083-2013
Date of alert: 2013-07-16
Country / jurisdiction: Germany
Risk level: Class II
Risk type: recall
Brand: Brainlab AG
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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