The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0538-2025·Announced 2024-12-04

Philips dS Breast MRI System Recalled for Patient Safety Hazard

Philips dS Breast 16ch 3.0T MRI systems are being recalled due to a potential safety issue that could harm patients during medical scans. The FDA-mandated Class II recall affects 5,231 units distributed nationwide.

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: This is an FDA Class II medical device recall for a potential patient safety hazard during medical imaging procedures where no illnesses or injuries have been reported, meeting the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

The Philips dS Breast 16ch 3.0T is a magnetic resonance imaging (MRI) system used for breast imaging procedures. The U.S. Food and Drug Administration (FDA) issued a Class II recall affecting approximately 5,231 units distributed nationwide in the United States.

The recall addresses a potential safety issue where a patient may be harmed while preparing for or during a scan. The FDA recall notice does not specify the precise nature of the hazard or available corrective actions.

Individuals who are scheduled for breast MRI procedures using affected equipment should contact their healthcare provider or imaging facility for information about this recall. Hospitals and imaging centers operating the Philips dS Breast 16ch 3.0T should contact the manufacturer, Philips North America LLC, for guidance.

The recalled product

Product
dS Breast 16ch 3.0T
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Imaging / MRI
Hazard
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: 453530280731
  • 459801290741
  • 459801290744
  • 459801729891
  • 459801729892
  • UDI: 00884838065840
  • 00884838086197
  • 00884838098381
  • 00884838118041
  • Serial No. 538
  • 170
  • 437
  • 14
  • 124
  • 189
  • 291
  • 194
  • 516
  • 412
  • 154

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 →

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