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

Recall Z-1846-2021 — ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient

U.S. FDA — Device Enforcement · Germany · 2021-05-14 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1846-2021
Date of alert: 2021-05-14
Country / jurisdiction: Germany
Risk level: Class II
Risk type: recall
Brand: Brainlab AG
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 04056481142315

Reported risk: Display of potential patient movement might be delayed to the user for high dose treatments.

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.

Related