The Recall Desk
HighFDA (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.

What this means for you

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

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.

Related recalls

Same category