Agency classClass IIOur severity:High FDA (Devices)·Z-0463-2023·Announced 2022-12-14

Philips MR 7700 System Upgrade Recalled Due to Gradient Coil Fire Risk

Philips is recalling the Upgrade to MR 7700 System (Model 782130) because the gradient coil may act as a heat source and produce smoke or fire. Affected units should not be operated until Philips provides further guidance.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with potential for fire and smoke generation in medical imaging equipment, which constitutes a risk-of-harm scenario. No injuries or illnesses are reported in the source material, supporting a High severity score per the rubric.

Plain-English summary

Philips North America Llc is recalling the Upgrade to MR 7700 System, Model Number 782130, distributed nationwide in the United States.

The gradient coil component in this MRI system upgrade may act as a heat source with the potential to produce smoke and/or fire. This poses a risk during normal operation of the device.

If you have received this upgrade, discontinue use of the system immediately and contact Philips North America Llc for further instructions. The manufacturer will provide information about corrective actions, repair, or replacement options.

The recalled product

Product: Philips Upgrade to MR 7700 System, Model Number 782130
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging
Hazard: fire
smoke

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Model 782120: UDI-DI: 00884838104402
Serial Numbers: 45298 45301

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Same manufacturer · Philips North America Llc

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Same hazard · fire