Philips North America Llc recalls SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Sy

Recalled July 3, 2024 · FDA recall Z-2164-2024 · Philips North America

Hazard

Potential for coils to heat up and harm patients (burn). · FDA Class I

Units

307 units

Sold at

Worldwide distribution: US (Nationwide) and OUS (Foreign): Afghanistan, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Papua New Guinea, Peru, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, T¿rkiye, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam.

Description

Potential for coils to heat up and harm patients (burn).

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, 989603050642.

Manufacturer(s)

Philips North America Llc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →