The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0390-2024·Announced 2023-11-29

Philips Achieva 1.5T MRI Device Recalled for Gradient Coil Fire Risk

Philips is recalling 68 Achieva 1.5T MRI machines due to potential gradient coil component failure that could produce smoke and fire. No injuries have been reported.

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: FDA Class II recall with potential for fire and smoke hazards from gradient coil component failure. No injuries or incidents reported, but the risk-of-harm classification justifies High severity per the rubric for products with unreported injury risk.

Plain-English summary

Philips North America LLC is recalling 68 units of the Achieva 1.5T Conversion MRI device. The recall addresses a potential component failure in the gradient coil that could produce smoke and/or fire.

The affected devices have been distributed nationwide in the United States and internationally across more than 40 countries worldwide.

The FDA has classified this as a Class II recall.

The recalled product

Product
Achieva 1.5T Conversion
Manufacturer
Philips North America Llc
Category
Medical Device — MRI Scanner
Hazard
Affected units
68

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. 781283 & 781346
  • UDI-DI: (01)00884838009806(21)39001
  • (01)00884838009806(21)39027
  • (01)00884838009806(21)39028
  • (01)00884838009806(21)39030
  • (01)00884838009806(21)39032
  • (01)00884838009806(21)39039
  • (01)00884838009806(21)39053
  • (01)00884838009806(21)39059
  • (01)00884838009806(21)39061
  • (01)00884838009806(21)39062
  • (01)00884838009806(21)39064
  • (01)00884838009806(21)39065
  • (01)00884838009806(21)39066
  • (01)00884838009806(21)39067
  • (01)00884838009806(21)39072
  • (01)00884838009806(21)39073
  • (01)00884838009806(21)39074
  • (01)00884838009806(21)39075
  • (01)00884838009806(21)39078

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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