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

Recall Z-2748-2018 — ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that ca

U.S. FDA — Device Enforcement · United States · 2018-06-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2748-2018
Date of alert: 2018-06-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Medical Solutions USA, Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10849000

Reported risk: Potential hardware issue which may cause thermal effects and possible damage to system parts.

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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