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

Recall Z-1029-2013 — Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

U.S. FDA — Device Enforcement · United States · 2012-12-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1029-2013
Date of alert: 2012-12-20
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: Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland), Inc. is issuing a software update to address the issues.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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-1029-2013 — Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

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