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

Recall Z-0706-2017 — Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents.

U.S. FDA — Device Enforcement · United States · 2016-11-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0706-2017
Date of alert: 2016-11-14
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: A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0706-2017 — Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents.

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