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

Recall Z-1294-2022 — Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000

U.S. FDA — Device Enforcement · United States · 2022-06-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1294-2022
Date of alert
2022-06-10
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)
04056869046877
Reported risk: A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.
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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