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

Recall Z-0928-2014 — XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.

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-0928-2014
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: When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.

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.

Recall Z-0928-2014 — XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.

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