FDA Device recall Z-0353-2025

Philips Zenition 70, Model Number: 718133

FDA Device
Class II
ongoing
Published 2024-11-20

On 2024-11-20 the FDA classified a Class II recall of Philips Zenition 70, Model Number: 718133 by Philips Medical Systems Nederland B V, citing potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0353-2025
Classification	Class II
Status	ongoing
Initiated	2024-10-07
Published	2024-11-20
Last updated	2026-09-13 11:57 UTC
Company	Philips Medical Systems Nederland B V
Distribution	US

Product

Philips Zenition 70, Model Number: 718133

Reason

Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.

Identifiers

code_info	Model Number: 718133; UDI-DI: (01)00884838091528(21); Serial Numbers: 420, 4093, 2851, 3947, 2571, 4211, 3325, 3326, 23… Model Number: 718133; UDI-DI: (01)00884838091528(21); Serial Numbers: 420, 4093, 2851, 3947, 2571, 4211, 3325, 3326, 2324, 3665, 491, 480, 579, 580, 581, 582, 4138, 71, 3657, 3660, 3889, 669, 670, 671, 233, 3416, 4351, 4352, 4353, 4355, 3971, 3972, 4387, 4278, 2880, 3366, 4062, 4063, 3374, 4201, 4083, 1290, 3894, 932, 933, 4309, 1796, 3355, 3680, 4156, 562, 1983, 4206, 3395, 1310, 3758, 63, 1787, 2888, 684, 235, 557, 4014, 2056, 3658, 3661, 1801, 108, 109, 3354, 572, 1901, 4431, 1086, 1868, 1899, 1758, 2081, 4223, 626, 652, 654, 655, 829, 1786, 2957, 3800, 1904, 3393, 4155, 4302, 3523, 4170, 4432, 651, 85, 4013, 3973, 1902, 563, 2202, 1903, 4386, 234, 2720, 202, 553, 3686, 822, 672, 3631, 72, 3892, 3893, 3895, 3896, 4176, 3491, 2958, 1219, 3392, 653, 1195, 1900, 4147, 2938, 1072, 101, 103, 2106, 1569, 3394, 1848, 1852, 4020, 4186, 3604, 106, 4096, 561, 1802, 4094, 3348, 1837, 944, 1192, 1625, 1194, 4396, 4279, 4280, 3683, 1944, 3940, 2887, 1204, 62, 1536, 1212, 20, 52, 1675, 2380, 2381

code_info

Model Number: 718133; UDI-DI: (01)00884838091528(21); Serial Numbers: 420, 4093, 2851, 3947, 2571, 4211, 3325, 3326, 23…

Model Number: 718133; UDI-DI: (01)00884838091528(21); Serial Numbers: 420, 4093, 2851, 3947, 2571, 4211, 3325, 3326, 2324, 3665, 491, 480, 579, 580, 581, 582, 4138, 71, 3657, 3660, 3889, 669, 670, 671, 233, 3416, 4351, 4352, 4353, 4355, 3971, 3972, 4387, 4278, 2880, 3366, 4062, 4063, 3374, 4201, 4083, 1290, 3894, 932, 933, 4309, 1796, 3355, 3680, 4156, 562, 1983, 4206, 3395, 1310, 3758, 63, 1787, 2888, 684, 235, 557, 4014, 2056, 3658, 3661, 1801, 108, 109, 3354, 572, 1901, 4431, 1086, 1868, 1899, 1758, 2081, 4223, 626, 652, 654, 655, 829, 1786, 2957, 3800, 1904, 3393, 4155, 4302, 3523, 4170, 4432, 651, 85, 4013, 3973, 1902, 563, 2202, 1903, 4386, 234, 2720, 202, 553, 3686, 822, 672, 3631, 72, 3892, 3893, 3895, 3896, 4176, 3491, 2958, 1219, 3392, 653, 1195, 1900, 4147, 2938, 1072, 101, 103, 2106, 1569, 3394, 1848, 1852, 4020, 4186, 3604, 106, 4096, 561, 1802, 4094, 3348, 1837, 944, 1192, 1625, 1194, 4396, 4279, 4280, 3683, 1944, 3940, 2887, 1204, 62, 1536, 1212, 20, 52, 1675, 2380, 2381

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-0353-2025%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.