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

Recall Z-0727-2021 — ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

U.S. FDA — Device Enforcement · United States · 2020-12-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0727-2021
Date of alert
2020-12-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
PHILIPS HOME HEALTHCARE SOLUTION
Product category
device
Product type
Devices
Reported risk: After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.
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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