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

Recall Z-3216-2018 — INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

U.S. FDA — Device Enforcement · United States · 2018-07-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3216-2018
Date of alert
2018-07-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Electronics North America Corporation
Product category
device
Product type
Devices
Reported risk: There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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