POWERLED TM recallZ-3224-2026 · Maquet SAS · initiated Aug 7, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet SAS or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Process control
What the company is doing
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].
Recall details
- Recall number
- Z-3224-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 7, 2026
- Posted by the FDA
- Sep 18, 2026
- Recalling firm
- Maquet SAS
- Quantity
- 667
- Product code
- FSY
- FDA submissions
- K070442
- Distribution
- US Nationwide distribution.
Product description
PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;
Code information (models, lots, serial numbers)
Show the full code information (8k characters)
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;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- POWERLED TM ARD568474114AMaquet Sas · Light, surgical, ceiling mounted2 recalls1 report
Product lines
Other devices under the same FDA submission
299 devices cleared under K070442 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- POWERLED TM ARDPWD259001AMaquet Sas · Light, surgical, ceiling mounted1 recall14 reports
- POWERLED TM ARD568425010AMaquet Sas · Light, surgical, ceiling mounted1 recall11 reports
- POWERLED TM ARD568415010AMaquet Sas · Light, surgical, ceiling mounted1 recall5 reports
- POWERLED TM ARD568446710AMaquet Sas · Light, surgical, ceiling mounted1 recall5 reports
- POWERLED TM ARD568410010AMaquet Sas · Light, surgical, ceiling mounted1 recall5 reports
- POWERLED TM ARD568411710AMaquet Sas · Light, surgical, ceiling mounted1 recall4 reports
- POWERLED TM ARD568411110AMaquet Sas · Light, surgical, ceiling mounted1 recall3 reports
- POWERLED TM ARD568420710AMaquet Sas · Light, surgical, ceiling mounted1 recall3 reports
- NA ARD515031660AMaquet Sas · Light, surgical, ceiling mounted1 recall2 reports
- POWERLED TM ARD568446512AMaquet Sas · Light, surgical, ceiling mounted1 recall2 reports
- POWERLED TM ARD568420051AMaquet Sas · Light, surgical, ceiling mounted1 recall2 reports
- POWERLED TM ARD568420752AMaquet Sas · Light, surgical, ceiling mounted1 recall2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page