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

Recall Z-1713-2016 — Philips Healthcare Brilliance 64 Computed Tomography X-Ray System

U.S. FDA — Device Enforcement · United States · 2015-09-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1713-2016
Date of alert
2015-09-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Healthcare
Product category
device
Product type
Devices
Reported risk: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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