Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2415-2021·Announced 2021-09-15

MRI System Tabletop May Fail to Move, Delaying Patient Evacuation

Philips MRI systems (Model 781260) may have a tabletop malfunction in manual mode that prevents complete movement, potentially delaying patient evacuation and treatment.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported injuries or incidents. The hazard is theoretical—a mechanical malfunction that could delay patient evacuation rather than cause direct physical harm. Class II recalls without reported injury typically fall into the Moderate category.

Plain-English summary

Philips is recalling 566 SmartPath to dStream 1.5T MRI systems (Model 781260) worldwide. These diagnostic imaging devices are used to produce cross-sectional images, spectroscopic images, and spectra of the head, body, and extremities.

When operating in manual mode, the tabletop may not completely move in or out of the MRI bore. This mechanical failure could result in a delay in patient evacuation from the device and a potential delay in treatment.

The recalled systems are distributed worldwide, including throughout the United States and 80 additional countries. Healthcare facilities using these systems should identify any affected units by serial number from the FDA recall notice and follow manufacturer instructions for verification and remediation.

Patients and healthcare providers should contact Philips North America LLC or visit the FDA Medical Device Recall page (Z-2415-2021) for specific guidance regarding the tabletop issue and available solutions.

The recalled product

Product: SmartPath to dStream for 1.5T-a 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…
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging
Hazard: equipment-malfunction
Affected units: 566

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

Same manufacturer · Philips North America Llc

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Same hazard · equipment malfunction