The Recall Desk
SevereFDA (Devices)·Z-2164-2024·Announced 2024-07-03

Philips MR Torso Coil Recall: Potential Patient Burn Risk

Philips is recalling 307 SENSE XL TORSO COIL 3.0T units used in MR imaging systems worldwide due to potential for coils to overheat and cause patient burn injuries.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I designation requires a minimum severity score of 4 per rubric rules, as Class I recalls indicate reasonable probability of serious adverse health consequences.

Plain-English summary

Philips North America LLC is recalling the SENSE XL TORSO COIL 3.0T, a 16-element receive-only coil used for torso and abdomen imaging in Philips MR Intera and Achieva Systems. The recall encompasses 307 units with five model numbers (453567394941, 453567394942, 453567394943, 453567394945, 459801593182) and two additional kit models (989603050641, 989603050642).

The recall is due to the potential for affected coils to heat up during use, which could result in patient burn injuries.

The affected units have been distributed worldwide, including throughout the United States and to over 70 countries internationally. Specific serial numbers for each model are identified in the FDA recall notice.

Facilities with affected coils should discontinue use immediately and contact Philips for information on replacement or repair options.

The recalled product

Product
SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 98960
Manufacturer
Philips North America Llc
Hazard
  • burn-injury
  • device-overheating

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)

  • 100
  • 102
  • 104
  • 144
  • 192
  • 84
  • 98
  • 42. 3. Model Number 453567394943. Serial Numbers: 301
  • 228
  • 761
  • 87
  • 880
  • 814
  • 0174R3
  • 541
  • @001@0179R3
  • 0141R3
  • 0172R3
  • 0189R3
  • 0260R3

Distribution

Distributed nationwide across the United States.