Agency classClass IIOur severity:High FDA (Devices)·Z-0542-2025·Announced 2024-12-04

Mammotrak Interventional Coil 1.5T recalled for patient safety risk

Philips is recalling 5,231 units of the Mammotrak Interventional Coil 1.5T nationwide due to a potential safety issue that may harm patients during MRI preparation or scanning.

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 FDA Class II recall describes a potential safety issue with no reported injuries or deaths. Per the rubric, when no illnesses or injuries are reported and the hazard is theoretical, the maximum score is High (3).

Plain-English summary

Philips North America Llc is recalling 5,231 units of the Mammotrak Interventional Coil 1.5T, distributed nationwide throughout the United States. The device is used in diagnostic MRI procedures.

The FDA classified this as a Class II recall due to a potential safety issue where patients may be harmed while preparing for or during MRI scanning procedures. The specific mechanism or nature of the potential hazard is not detailed in the recall notice. Affected devices can be identified using reference code REF: 453530228882, UDI-DI: 00884838066779, and serial numbers: 69, 82, 143, 64, 77, 87, 76, 81, 134, 124, 141, 103, 135, 138, 73, 72, and 131.

Healthcare facilities and providers using this device should consult the FDA and Philips North America for additional information, risk assessment, and guidance on appropriate actions regarding continued use or device replacement.

The recalled product

Product: Mammotrak Interventional Coil 1.5T
Manufacturer: Philips North America Llc
Category: Medical Device — Interventional Coil / MRI
Hazard: patient-harm-risk
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 (19)

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

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 →

Same manufacturer · Philips North America Llc

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Same hazard · patient harm risk