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

Recall Z-1663-2013 — Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the th

U.S. FDA — Device Enforcement · United States · 2013-05-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1663-2013
Date of alert: 2013-05-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Medical Solutions USA, Inc
Product category: device
Product type: Devices

Reported risk: The information regarding the FILM Mode calibration may have been considered difficult to interpret when translated. SIEMENS HEALTHCARE CR / RADIATION ONCOLOGY had become aware that this issue may have resulted in mistreatment of patients.

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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