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

Recall Z-1165-2023 — Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472

U.S. FDA — Device Enforcement · United States · 2022-12-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1165-2023
Date of alert
2022-12-21
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)
10762472
Reported risk: Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
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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