Agency classClass IOur severity:Severe FDA (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.

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 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
Category: Medical Device — MRI Imaging Equipment
Hazard: burn-injury
overheating
Affected units: 14

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.

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 →

Same manufacturer · Philips North America Llc

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Same hazard · burn injury