The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0548-2025·Announced 2024-12-04

Philips ST SENSE Breast Imaging Coil Recalled for Patient Safety Risk

Philips is recalling 5,231 units of the ST SENSE Breast Dx Coil nationwide due to a potential safety issue that may harm patients during breast imaging scans. No injuries have been reported.

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 of a medical device with a potential patient safety risk during clinical use. No injuries or illnesses have been reported, placing this in the 'risk-of-harm products where injury has not yet been reported' category per the severity rubric.

Plain-English summary

Philips North America Llc is recalling the ST SENSE Breast Dx Coil, a medical imaging device used in breast imaging procedures.

The recall affects 5,231 units distributed nationwide in the United States. Affected devices are identified by serial numbers 55, 3, 9, 36, 40, 56, 35, 39, 80, 46, 29, 7, 28, 55, 47, and 54, with UDI-DI 00884838066823 and REF 453530264791.

The FDA has identified a potential safety issue where a patient may be harmed while preparing for or during a breast imaging scan. Patients who have undergone or are scheduled to undergo breast imaging with this device should consult their healthcare provider. Healthcare providers should contact Philips for guidance on managing affected coils and ensuring continued safe operations.

The recalled product

Product
ST SENSE Breast Dx Coil
Manufacturer
Philips North America Llc
Category
Medical Device — Medical Imaging / Breast Imaging
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 (18)

  • REF: 453530264791
  • UDI-DI: 00884838066823
  • Serial No. 55
  • 3
  • 9
  • 36
  • 40
  • 56
  • 35
  • 39
  • 80
  • 46
  • 29
  • 7
  • 28
  • 55
  • 47
  • 54.

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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