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

Recall Z-0280-2022 — Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

U.S. FDA — Device Enforcement · United States · 2021-05-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0280-2022
Date of alert
2021-05-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America Llc
Product category
device
Product type
Devices
Reported risk: Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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