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

Recall Z-2422-2021 — Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781356

U.S. FDA — Device Enforcement · United States · 2021-08-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2422-2021
Date of alert
2021-08-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838090040
Reported risk: When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
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.