Agency classClass IIOur severity:High FDA (Devices)·Z-0539-2025·Announced 2024-12-04

Philips Breast MRI System Recalled for Patient Safety Risk

Philips is recalling 5,231 units of the dS Breast 7ch 1.5T breast MRI system due to a potential safety issue that could harm patients during preparation or scanning.

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 for a potential patient safety issue occurring during medical imaging procedures. No injuries or illnesses have been reported, but the hazard is deemed significant enough to warrant a recall.

Plain-English summary

Philips North America LLC is recalling 5,231 units of the dS Breast 7ch 1.5T breast MRI system that were distributed nationwide in the United States. The company has identified a potential safety issue with the device.

According to the manufacturer, a patient may be harmed while preparing for or during a scan with this equipment. The FDA has classified this as a Class II recall.

Patients and healthcare facilities using this equipment should contact Philips North America LLC for further information and guidance regarding the affected devices.

The recalled product

Product: dS Breast 7ch 1.5T
Manufacturer: Philips North America Llc
Category: Medical Device — Breast MRI
Hazard: device-defect
patient-harm
Affected units: 5,231

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 (20)

REF: 453530280881
453530280882
459801290431
459801290432
UDI: 00884838066847
00884838086111
Serial No. 507
648
409
133
596
421
613
68
121
132
757
787
622
538

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 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 13 products in this recall →

Same manufacturer · Philips North America Llc

See all →

High
Philips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
Moderate
Philips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
Moderate
Philips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
Moderate
Philips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Moderate
Philips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30

Same hazard · device defect