FDA Device recall Z-2165-2024

SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems

FDA Device
Class I
ongoing
Published 2024-07-03

On 2024-07-03 the FDA classified a Class I recall of SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems by Philips North America, citing potential for coils to heat up and harm patients (burn).

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2165-2024
Classification	Class I
Status	ongoing
Initiated	2024-06-05
Published	2024-07-03
Last updated	2026-09-13 11:57 UTC
Company	Philips North America
Distribution	US

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.

Reason

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

Identifiers

code_info	UDI-DI: N/A. 1. Model Number 453567502281. Serial Numbers: 190, 187, 71, 60, 24, 244, 36, 151, 245, 29, 128, 151, 167,… UDI-DI: N/A. 1. Model Number 453567502281. Serial Numbers: 190, 187, 71, 60, 24, 244, 36, 151, 245, 29, 128, 151, 167, 179, 185, 187, 190, 29, 32, 34, 36, 38, 51. 2. Model Number 453567502282. Serial Numbers: 112, 27, 66, 67, 68, 75. 3. Model Number 453567502283. Serial Numbers: 1025, 1028, 1029, 1031, 1036, 1050, 1052, 1054, 1064, 1104, 1106, 111, 1112, 1131, 1134, 1135, 115, 1151, 1152, 1195, 1205, 1213, 1217, 1219, 1350, 1354, 1359, 1366, 1367, 1395, 1411, 208, 221, 243, 257, 279, 289, 357, 362, 4, 426, 450, 478, 50, 514, 519, 527, 530, 535, 616, 618, 65, 650, 678, 690, 702, 703, 723, 724, 755, 778, 787, 790, 873, 874, 923, 927, 928, 954, 957, 959, 962, 964, 973, 980, 984. 4. Model Number 453567502284. Serial Numbers: 1043, 200, 0086R4, 0131R4, 01444R3, 0156R4, 0163R4, 0296R3, 0312R3, 0480R3, 0516R3, 0580R3, 0603R3, 0629R3, 0673R3, 0696R3, 0884R3, 0939R4, 0979R3, 1, 1000, 1001, 1003, 1005, 1012, 1017, 1019, 1023, 1027, 1030, 1032, 1041, 1049, 1053, 1055, 1058, 1060, 1062, 106

code_info

UDI-DI: N/A. 1. Model Number 453567502281. Serial Numbers: 190, 187, 71, 60, 24, 244, 36, 151, 245, 29, 128, 151, 167,…

UDI-DI: N/A. 1. Model Number 453567502281. Serial Numbers: 190, 187, 71, 60, 24, 244, 36, 151, 245, 29, 128, 151, 167, 179, 185, 187, 190, 29, 32, 34, 36, 38, 51. 2. Model Number 453567502282. Serial Numbers: 112, 27, 66, 67, 68, 75. 3. Model Number 453567502283. Serial Numbers: 1025, 1028, 1029, 1031, 1036, 1050, 1052, 1054, 1064, 1104, 1106, 111, 1112, 1131, 1134, 1135, 115, 1151, 1152, 1195, 1205, 1213, 1217, 1219, 1350, 1354, 1359, 1366, 1367, 1395, 1411, 208, 221, 243, 257, 279, 289, 357, 362, 4, 426, 450, 478, 50, 514, 519, 527, 530, 535, 616, 618, 65, 650, 678, 690, 702, 703, 723, 724, 755, 778, 787, 790, 873, 874, 923, 927, 928, 954, 957, 959, 962, 964, 973, 980, 984. 4. Model Number 453567502284. Serial Numbers: 1043, 200, 0086R4, 0131R4, 01444R3, 0156R4, 0163R4, 0296R3, 0312R3, 0480R3, 0516R3, 0580R3, 0603R3, 0629R3, 0673R3, 0696R3, 0884R3, 0939R4, 0979R3, 1, 1000, 1001, 1003, 1005, 1012, 1017, 1019, 1023, 1027, 1030, 1032, 1041, 1049, 1053, 1055, 1058, 1060, 1062, 106

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2165-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.