Official recall record

SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.

US FDA — Medical Devices · 2024-01-03 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2024-01-03
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 00884838095083
Brand on record: Philips North America

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 3 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2021-08-11 · US FDA — Medical Devices
SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic d
2025-12-03 · US FDA — Medical Devices
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
2025-05-13 · US FDA — Medical Devices
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145

Other recalls from this brand

2026-08-28 · US FDA — Medical Devices
Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T),
2026-08-28 · US FDA — Medical Devices
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13
2026-08-28 · US FDA — Medical Devices
Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3.

All 58 official recall notices naming Philips North America on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.