Philips North America Llc: Medical Device Recall in 2024 - (Recall #: Z-0547-2025)

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:

ST SENSE Breast Coil

Product Classification:

Class II

Date Initiated: November 4, 2024

Date Posted: December 4, 2024

Recall Number: Z-0547-2025

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: 453530054571; UDI-DI: 00884838066625; Serial No. 36577, 36597, 36664, 36706, 36540, 36604, 36590, 36670, 36671, 36704, 36710, 36712, 36524, 36555, 36519, 36521, 36570, 36573, 36582, 36580, 36581, 36603, 36619, 36663, 36680, 36711, 36548, 36576, 36589, 36606, 36523, 36567, 36572, 36601, 36639, 36661, 36536, 36588, 36635, 36631, 36668, 36613, 36677, 36530, 36556, 36661, 36575, 36592, 36632, 36657, 36669, 36602, 36674, 36703, 36534, 36551, 36541, 36549, 36547, 36525, 36526, 36528, 36574, 36571, 36595, 36614, 36605, 36600, 36636, 36634, 36662, 36641.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated