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

Recall Z-0978-2022 — Artis Q.zen floor, Model Number 10848353

U.S. FDA — Device Enforcement · United States · 2022-02-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0978-2022
Date of alert
2022-02-23
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)
4056869010014
Reported risk: If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
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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