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

Recall Z-2163-2024 — SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

U.S. FDA — Device Enforcement · United States · 2024-06-05 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2163-2024
Date of alert
2024-06-05
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Philips North America Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
453567141882
Reported risk: Potential for coils to heat up and harm patients (burn).
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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