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

Recall Z-1538-2012 — Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide

U.S. FDA — Device Enforcement · United States · 2011-10-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1538-2012
Date of alert
2011-10-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Healthcare Inc.
Product category
device
Product type
Devices
Reported risk: When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. .When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. The failure happened when component supplie
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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