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

Recall Z-3190-2018 — ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000

U.S. FDA — Device Enforcement · United States · 2018-07-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3190-2018
Date of alert
2018-07-29
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: Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).
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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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.