The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0537-2025·Announced 2024-12-04

Philips dS Breast 16ch 1.5T MRI Recalled for Patient Safety Risk

Philips North America is recalling approximately 5,231 dS Breast 16ch 1.5T MRI systems nationwide due to a potential safety issue that could harm patients during scan preparation or procedures.

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 a Class II recall of a medical device with potential to cause patient harm during use, but no injuries, illnesses, or deaths have been reported. Per the severity rubric, a risk-of-harm medical device where injury has not yet been reported qualifies as High.

Plain-English summary

Philips North America is recalling the dS Breast 16ch 1.5T, a magnetic resonance imaging system designed for breast imaging. Approximately 5,231 units have been distributed throughout the United States.

The FDA has classified this recall as Class II due to a potential safety issue that could cause patient harm during scan preparation or while a patient undergoes a scan. No illnesses or injuries have been reported to date.

Patients and healthcare facilities with affected devices should contact Philips North America or their healthcare provider to determine whether their device is affected and to receive guidance on next steps. Facilities should take appropriate precautions regarding use of potentially affected units until the issue has been resolved.

The recalled product

Product
dS Breast 16ch 1.5T
Manufacturer
Philips North America Llc
Category
Medical Device — Breast 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: 453530280721
  • 453530280723
  • 459801290511
  • 459801290514
  • 459801729882
  • UDI: 00884838066854
  • 00884838086425
  • 00884838118393
  • Serial No. 482
  • 508
  • 119
  • 40
  • 318
  • 394
  • 443
  • 41
  • 286
  • 120
  • 264
  • 412

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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