Philips SENSE XL TORSO COIL Recall Due to Potential Patient Burn Hazard
Philips is recalling SENSE XL TORSO COIL units used in MRI imaging because the coils may heat up excessively and cause patient burns. This FDA Class I recall affects 729 units distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4 per the rubric. The hazard involves potential for patient burn injury from thermal effects during medical device use, which represents a significant risk of harm.
Plain-English summary
Philips North America LLC is recalling the SENSE XL TORSO COIL 1.5T, a 16-element receive-only coil used for torso and abdomen imaging in Philips MR Intera and Achieva MRI systems. The recall affects 729 units across four model numbers: 453567141882, 453567141883, 989603014351, and 989603014352.
The FDA has classified this as a Class I recall because the coils have the potential to heat up excessively during patient imaging procedures and cause burn injuries. The coils have been distributed worldwide, including throughout the United States and to numerous countries in Europe, Asia, the Middle East, Africa, and the South Pacific.
Healthcare facilities and imaging centers that use these specific model numbers should verify their equipment serial numbers against the complete list provided in the FDA recall notice. Affected units should be immediately taken out of service and not used for patient imaging until receiving further instructions from Philips North America LLC.
The recalled product
- Product
- SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
- Manufacturer
- Philips North America Llc
- Affected units
- 729
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 453567141882. Serial Numbers: 137
- 141
- 145
- 147
- 157
- 18
- 188
- 19
- 191
- 197
- 251
- 291
- 301
- 320
- 356
- 360
- 364
- 366
- 371
- 39
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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