Z-3224-2026Class II

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

Name: Z-3224-2026 PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1...
Creator: Maquet SAS
Published: 2026-08-07
License: https://open.fda.gov/license/

Maquet SAS / initiated 2026-08-07 / Open, Classified

FDA source

Recall record

Recall number: Z-3224-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-07
Posted: 2026-09-18
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;
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
FDA 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 [email protected].
Quantity in commerce: 667
Distribution: US Nationwide distribution.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3224-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3224-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18

Product code FSY

K070442Class IIPowerled Surgical Light SystemMaquet S.A. / cleared 2007-03-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)