The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0536-2025·Announced 2024-12-04

Philips Achieva TX Interventional Coil 3.0T Recalled for Patient Safety Risk

Philips recalls the Achieva TX Interventional Coil 3.0T (5,231 units) for a potential safety issue that may harm patients during MRI scan preparation or procedures.

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: Classified as FDA Class II with no reported patient injuries or illnesses. The source describes the hazard as potential rather than confirmed. Per the severity rubric, a Class II medical device recall describing a risk-of-harm scenario where injury has not yet been reported qualifies as High (Score 3).

Plain-English summary

Philips North America LLC is recalling the Achieva TX Interventional Coil 3.0T, a medical device used in MRI imaging procedures at 3.0 Tesla field strength.

The recall addresses a potential safety issue where patients may be harmed while preparing for or during an MRI scan. The specific failure mode is not detailed in the available recall information.

Approximately 5,231 units were distributed nationwide throughout the United States. The recall was issued by the FDA as a Class II recall.

The recalled product

Product
Achieva TX Interventional Coil 3.0T
Manufacturer
Philips North America Llc
Category
Medical Device — MRI Interventional Coil
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 (20)

  • REF: 453530264711
  • UDI: 00884838066175
  • Serial No. 171
  • 318
  • 274
  • 333
  • 116
  • 120
  • 169
  • 177
  • 449
  • 430
  • 280
  • 460
  • 301
  • 287
  • 539
  • 545
  • 182
  • 502

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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