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

Recall Z-1354-2016 — Ingenuity Core Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

U.S. FDA — Device Enforcement · United States · 2016-02-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1354-2016
Date of alert
2016-02-05
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 was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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