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

Recall Z-2259-2023 — Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146

U.S. FDA — Device Enforcement · United States · 2023-04-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2259-2023
Date of alert
2023-04-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838104481
Reported risk: Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
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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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.