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

Recall Z-0733-2022 — ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.

U.S. FDA — Device Enforcement · Germany · 2022-02-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0733-2022
Date of alert
2022-02-25
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: The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
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.

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