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

Recall Z-0951-2024 — Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.

U.S. FDA — Device Enforcement · United States · 2024-01-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0951-2024
Date of alert
2024-01-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838068452
Reported risk: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
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.