The Recall Desk
SevereFDA (Devices)·Z-2165-2024·Announced 2024-07-03

Philips SENSE XL Torso Coil 1.5T Recalled for Overheating Risk

Philips recalled 14 SENSE XL Torso Coils worldwide due to potential overheating. The coils could heat up during use 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 recall. The device poses potential for patient burn injuries from overheating during use. No reported illnesses or injuries are stated in the source.

Plain-English summary

Philips North America LLC is recalling the SENSE XL TORSO COIL 1.5T Mk2, a 16-element receive-only coil used with Philips MR Intera and Achieva MRI systems for torso and abdominal imaging. Fourteen units across seven model numbers have been affected: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, and 459801585212.

The coils may overheat during clinical use, creating a potential risk of patient burn injuries.

The affected coils were distributed worldwide, including throughout the United States and internationally. Healthcare facilities using these coils should stop using them and contact Philips for instructions on replacement or repair. The FDA has classified this as a Class I recall.

The recalled product

Product
SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
Manufacturer
Philips North America Llc
Hazard
  • burn-injury
  • 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)

  • UDI-DI: N/A. 1. Model Number 453567502281. Serial Numbers: 190
  • 187
  • 71
  • 60
  • 24
  • 244
  • 36
  • 151
  • 245
  • 29
  • 128
  • 167
  • 179
  • 185
  • 190
  • 32
  • 34
  • 38
  • 51. 2. Model Number 453567502282. Serial Numbers: 112
  • 27

Distribution

Distributed nationwide across the United States.