Philips North America Llc: Medical Device Recall in 2024 - (Recall #: Z-0542-2025)

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:

Mammotrak Interventional Coil 1.5T

Product Classification:

Class II

Date Initiated: November 4, 2024
Date Posted: December 4, 2024
Recall Number: Z-0542-2025
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: 453530228882; UDI-DI: 00884838066779; Serial No. 69, 82, 143, 64, 77, 87, 76, 81, 134, 124, 141, 103, 135, 138, 73, 72, 131.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated