The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0389-2024·Announced 2023-11-29

Philips Achieva 1.5T MRI systems recalled for potential gradient coil fire risk

Philips is recalling Achieva 1.5T MRI systems due to potential gradient coil failure that could produce smoke and/or fire. Approximately 520 units have been distributed nationwide and internationally.

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 is an FDA Class II medical device recall involving a theoretical risk-of-harm hazard (potential fire and smoke from gradient coil failure) with no reported injuries or hospitalizations, meeting the rubric criterion for High severity.

Plain-English summary

Philips North America LLC is recalling Achieva 1.5T magnetic resonance imaging (MRI) systems due to a potential failure in the gradient coil component.

The potential component failure in the gradient coil could produce smoke and/or fire, posing a risk to patients and healthcare personnel in the vicinity of affected devices.

Approximately 520 units of the Achieva 1.5T have been distributed domestically throughout the United States and internationally to more than 50 countries, including Canada, Australia, Japan, Germany, France, and many others.

The recalled product

Product
Achieva 1.5T
Manufacturer
Philips North America Llc
Category
Medical Device — Medical Imaging / MRI
Hazard
Affected units
520

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)

  • Product No. 781178
  • 781196
  • 781296
  • & 781343
  • UDI-DI: (01)00884838004108(21)8524
  • (01)00884838004108(21)32039
  • (01)00884838004108(21)32052
  • (01)00884838004108(21)32083
  • (01)00884838004108(21)32087
  • (01)00884838004108(21)32097
  • (01)00884838004108(21)32103
  • (01)00884838004108(21)32118
  • (01)00884838004108(21)32123
  • (01)00884838004108(21)32150
  • (01)00884838004108(21)32153
  • (01)00884838004108(21)32154
  • (01)00884838004108(21)32186
  • (01)00884838004108(21)32223
  • (01)00884838004108(21)32226
  • (01)00884838004108(21)32228

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

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