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

Recall Z-1081-2014 — RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practi

U.S. FDA — Device Enforcement · United States · 2013-11-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1081-2014
Date of alert: 2013-11-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Elekta, Inc.
Product category: device
Product type: Devices

Reported risk: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

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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