Maquet SAS: PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;

Recall number

Z-3224-2026

Recalling firm

Maquet SAS

Product

PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;

Status

Open, Classified

Initiated

2026-08-07

Posted

2026-09-18

Terminated

not on file

Reason

The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.

Root cause

Process control

Action

On August 7, 2026 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Identify any affected light(s) in your facility. Do not use affected light(s) until Getinge has completed the inspection and any required repairs. You may continue to use the room where the light is located. The light enclosure must remain closed; use an alternative light source as needed. 2. Forward this notification to anyone in your organization, or any organization Where the affected devices were transferred, who needs to be aware. 3. Complete and return the enclosed response form to recallresponses.qrc@getinge.com.

Quantity

667

Distribution

US Nationwide distribution.

Lot, serial or model codes

1. Model Number: ARD568474114A; UDI-DI: N/A; Serial Numbers: 500190, 500194, 500201, 500203, 500209, 500216, 500218, 500197, 500204, 500210, 500211, 500212, 500213, 500214, 500217, 500206, 500390, 500393, 500397, 500414, 500416, 500417, 500418, 500451, 500266, 500284, 500291, 500293, 500294, 500299, 500300, 500301, 500302, 500306, 500307, 500308, 500117, 500116, 500273, 500274, 500399, 500400, 500402, 500168, 500188, 500192, 500196, 500208, 500219, 500221, 500228, 500233, 500237, 500240, 500247, 500159, 500207, 500215, 500396, 500415, 500419, 500429, 500430, 500433, 500434, 500437, 500439, 500440, 500443, 500478, 500394, 500398, 500403, 500407, 500391, 500404, 500060, 500061, 500062, 500063, 500080, 500081, 500086, 500089, 500094, 500095, 500096, 500099, 500105, 500106, 500111, 500112, 500118, 500119, 500392, 500395, 500405, 500406, 500409, 500427, 500428, 500435, 500436, 500238, 500249, 500251, 500254, 500256, 500258, 500259, 500260, 500261, 500262, 500277, 500278, 500285, 500296, 500304, 500309, 500311, 500312, 500316, 500323, 500328, 500331, 500332, 500338, 500198, 500200, 500067, 500073, 500074, 500076, 500079, 500082, 500069, 500161, 500078, 500051, 500053, 500093, 500100, 500107, 500108, 500113, 500114, 500065, 500070, 500071, 500072, 500075, 500077, 500084, 500085, 500087, 500143, 500145, 500152, 500164, 500167, 500178, 500179, 500253, 500255, 500267, 500268, 500286, 500287, 500292, 500224, 500225, 500229, 500235, 500236, 500128, 500134, 500137, 500148, 500149, 500129, 500173, 500177, 500182, 500184, 500185, 500189, 500195, 500199, 500205, 500169, 500170, 500180, 500142, 500144, 500166, 500172, 500174, 500175, 500181, 500242, 500160, 500162, 500165, 500176, 500157, 500158, 500163, 500171, 500068, 500088, 500131, 500132, 500133, 500151, 500220, 500223, 500226, 500241, 500245, 500248, 500064, 500313, 500315, 500317, 500318, 500320, 500324, 500325, 500326, 500327, 500329, 500330, 500333, 500334, 500335, 500337, 500092, 500097, 500098, 500101, 500102, 500103, 500104, 500109, 500110, 500115, 500120, 500121, 500408, 500359, 500361, 500362, 500363, 500364, 500365, 500368, 500369, 500370, 500372, 500380, 500232, 500239, 500263, 500264, 500269, 500271, 500272, 500373, 500374, 500375, 500386, 500387, 500453, 500454, 500455, 500456, 500461, 500462, 500492, 500493, 500279, 500303, 500305, 500413, 500422, 500425, 500426, 500431, 500438, 500444, 500445, 500446, 500130, 500135, 500136, 500138, 500141, 500146, 500150, 500153, 500154, 500280, 500281, 500282, 500297, 500028, 500029, 500031, 500032, 500033, 500036, 500040, 500041, 500042, 500049, 500056, 500183, 500193, 500257, 500270, 500275, 500276, 500401, 500410, 500411, 500412, 500423, 500424, 500441, 500442, 500447, 500448, 500420, 500421, 500432, 500243, 500037, 500083, 500125, 500126, 500127, 500139, 500140, 500147, 500250, 500252, 500265, 500283, 500288, 500289, 500290, 500295, 500298, 500030, 500034, 500035, 500038, 500039, 500043, 500044, 500045, 500046, 500047, 500048, 500050, 500052, 500054, 500055, 500057, 500227, 500230, 500234, 500244, 500246, 500066, 500222, 500231, 500314, 500319, 500321, 500322, 500336, 500360, 500366, 500367, 500371, 500376, 500377, 500378, 500379, 500381, 500382, 500383, 500384, 500385, 500388, 500186; 2. Model Number: ARD567501286; UDI-DI: 03700712403478; Serial Numbers: 1314H000217400, 4014H000279430, 4014H000279432, 4014H000279433, 4014H000279434, 4014H000279437, 4014H000279438, 4314H000288228, 4314H000288229, 4314H000288232, 4314H000288233, 4314H000288234, 4314H000288237, 4314H000288239, 4314H000288257, 4314H000288258, 4314H000288259, 4714H000296081, 4717H000296095, 1315H000382641, 1715H000392775, 2115H000409030, 2115H000409038, 2115H000409040, 2115H000409062, 2113H000123425, 3613H000150570, 2115H000409063, 3015H000436557, 3015H000436569, 3015H000436571, 2115H000409065, 2115H000409067, 2615H000423256, 3015H000436561, 3015H000436566, 3015H000436570, 1314H000215902, 1314H000215904, 0116H000537022, 0716H000208366, 2816H000647716, 0615H000334882, 0615H000334887, 0615H000334891, 0815H000351763, 0815H000351768, 0815H000351780, 1314H000215893, 1314H000215894, 1314H000215896, 1314H000215900, 1314H000215903, 1314H000215907, 1314H000215885, 2114H000236788, 2613H000132823, 2613H000132825, 2613H000132826, 2613H000132827, 2613H000132828, 2614H000244892, 3613H000150571, 3613H000150572, 4014H000279429, 4014H000279431, 4314H000288230, 4314H000288235, 1314H000215886, 1314H000215895, 1314H000215898, 1314H000215899, 1314H000215908, 2114H000236778, 2114H000236779, 2114H000236787, 2114H000236789, 2114H000236790, 2614H000244886, 2115H000409051, 2115H000409058, 3015H000436556, 3015H000436558, 3015H000436568, 4314H000288231, 1314H000215888, 1314H000215889, 1314H000215906, 1314H000215879, 1314H000215880, 1314H000215881, 1314H000215882, 1314H000215890, 1314H000215892, 1314H000215897, 1314H000215901, 2614H000244885, 2113H000123420, 2113H000123421, 2113H000123423, 2113H000123424, 2113H000123426, 2113H000123427, 2113H000123429, 2613H000132824, 2816H000647710, 2614H000244884, 2614H000244889, 2114H000236777, 2114H000236782, 2114H000236785, 2614H000244877, 2614H000244878, 2614H000244883, 2614H000244890, 1314H000215905, 2115H000409039, 0116H000537017, 0116H000537020, 0116H000537021, 0116H000537023, 0116H000537024, 0116H000537025, 0116H000537026, 0615H000334878, 0615H000334881, 0715H000391839, 0716H000261478, 0716H000561475, 0716H000561479, 0716H000561493, 1314H000217399, 2215H000537018, 2615H000423253, 2816H000647709, 2816H000647712, 2816H000647714, 2916H000647713, 3015H000436560, 3015H000436564, 4314H000288260, 4714H000296097, 1314H000215883, 1314H000215884, 1314H000215887, 0815H000351782, 2115H000409029, 2114H000236780, 2114H000236781, 2114H000236783, 2114H000236784, 2114H000236786, 2614H000244879, 2614H000244880, 2614H000244887, 2614H000244888, 2614H000244891, 2115H000409027, 2115H000409055, 2115H000409032, 2115H000409034, 2115H000409053, 2115H000409064, 2115H000409070, 2615H000423252, 2615H000423254, 3015H000436563, 0116H000537019, 0716H000561481, 3613H000150569, 0615H000334888, 0615H000334889, 0716H000561477, 0716H000561480, 0615H000334883, 0615H000334884, 2115H000409068, 2115H000409069, 2615H000423258, 3015H000436559, 3015H000436562, 3015H000436565, 3015H000436567, 4314H000288236, 4314H000288240, 0615H000334885, 0615H000334886, 0615H000334890, 0815H000351765, 0815H000351767, 0815H000351771, 0815H000351776, 0815H000351777, 0815H000351779, 1314H000215891, 2614H000244881, 2614H000244882, 4014H000279436, 4314H000288238, 4314H000288261, 1813H000118088, 1813H000118093, 2613H000132815, 2613H000132818, 3613H000150533, 3613H000150534, 3613H000150537, 3613H000150538, 3613H000150541, 2613H000132811, 3613H000150544, 3613H000150545, 3613H000150546, 3613H000150547, 3613H000150548, 3613H000150565, 3613H000150566, 3613H000150567, 3613H000150568, 0815H000351774, 4014H000279428, 2115H000409054, 0815H000351773, 1315H000382643, 1315H000382644, 2115H000409028, 2115H000409033, 2115H000409035, 2115H000409036, 2115H000409037, 2115H000409052, 2115H000409056, 2115H000409057, 2115H000409059, 2115H000409060, 2115H000409061, 2816H000647715, 0815H000351775, 0815H000351778, 4014H000279435, 3613H000150535, 3613H000150536, 3613H000150539, 3613H000150540, 3613H000150542, 3613H000150543, 2115H000409031, 0815H000351764, 0815H000351766, 0815H000351769, 0815H000351770, 0815H000351772, 0815H000351781, 1813H000118090, 2113H0001231, 2113H000123428, 2613H000132800, 2613H000132801, 2613H000132802, 2613H000132803, 2613H000132804, 2613H000132806, 2613H000132807, 2613H000132808, 2613H000132809, 2613H000132810, 2613H000132812, 2613H000132813, 2613H000132814, 2813H000132805;

510(k) numbers

["K070442"]

PMA numbers

not on file

Product code

FSY

Firm FEI

3002465150

Firm city

not on file

Firm state

not on file

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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