Philips North America Llc: Medical Device Recall in 2024 - (Recall #: Z-0546-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

SENSE Breast Coil 3.0T 7ch

Product Classification:

Class II

Date Initiated: November 4, 2024

Date Posted: December 4, 2024

Recall Number: Z-0546-2025

Event ID: 95645

Reason for Recall:

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Status: Ongoing

Product Quantity: 5,231 units

Code Information:

REF: 453530089302; UDI-DI: 00884838065413; Serial No. 16, 7, 22, 52.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated