Recall Z-2164-2024— Philips North America Llc

Name: FDA recall Z-2164-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-05

Class I · Ongoing

Class I FDA medical device recall by Philips North America Llc, initiated 2024-06-05. It names 2 FDA 510(k) clearances: K052013, K043147. 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.. Reason: Potential for coils to heat up and harm patients (burn)..

Recalling firm: Philips North America Llc
Classification: Class I
Status: Ongoing
Initiated: 2024-06-05
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K052013 — ACHIEVA 1.5T & INERA 1.5T FAMILYPhilips Medical Systems Nederland B.V.·cleared 2005-08-02
K043147 — ACHIEVA FAMILYPhilips Medical Systems North America Co.·cleared 2005-02-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.