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

Recall Z-0176-2016 — Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

U.S. FDA — Device Enforcement · United States · 2015-09-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0176-2016
Date of alert
2015-09-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems (Cleveland) Inc
Product category
device
Product type
Devices
Reported risk: The firm discovered Ring/Dot artifact due to X-ray measurement error.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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