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

Recall Z-0306-2024 — Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

U.S. FDA — Device Enforcement · United States · 2023-10-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0306-2024
Date of alert
2023-10-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838103627
Reported risk: When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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