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

Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging System — recall Z-0931-2019

U.S. FDA — Device Enforcement · Netherlands · 2018-12-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0931-2019
Date of alert
2018-12-21
Country / jurisdiction
Netherlands
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems Nederlands
Product category
device
Product type
Devices
Reported risk: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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