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

Recall Z-2397-2023 — MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)

U.S. FDA — Device Enforcement · United States · 2023-06-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2397-2023
Date of alert
2023-06-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838104112
Reported risk: The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
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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