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FDA (Device enforcement)Recalled 2023-11-08class ii

Getinge Usa Sales Inc: Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A, PWDII755DF - ARDPWT629103A,

Hazard

A potential for a light system to fall in the operating room.

Details from the source

Reason for recall: A potential for a light system to fall in the operating room. Distribution: US Nationwide. Global Distribution. Quantity: 236793 units in total Lot/code info: All systems affected UDI-DI: 03700712414207 03700712407094 03700712407087 03700712407070 03700712406141 3700712407148 3700712407155 3700712407377 3700712407384 3700712407605 3700712407612 3700712407834 3700712407841 3700712406172 3700712406288 3700712406448 3700712406479 3700712406608 3700712406615 3700712406639 3700712406660 3700712416027 3700712419820 3700712408060 3700712408336 3700712411336 3700712411596 3700712406684 3700712406967 3700712406691 3700712406882 3700712416904 3700712416966 3700712417321 3700712419424 3700712418434 3700712409722 3700712409135 3700712417352 3700712418526 3700712418533 3700712409654 3700712409098 3700712417338 3700712416690 3700712416706 3700712409180 3700712408664 3700712417345 3700712416713 3700712416720 3700712409821 3700712409333 3700712417369 3700712416737 3700712416751 3700712409609 3700712409043 3700712417383 3700712416744 3700712416768 3700712409524 3700712409005 3700712412531 3700712412548 3700712412555 3700712410445 3700712410056 3700712417376 3700712416010 3700712413279 3700712410292 3700712409975 3700712414221 3700712414214 3700712415075 3700712415082 3700712415235 3700712415242 3700712415259 3700712415266 3700712417406 3700712419462 3700712418366 3700712409456 3700712408961 3700712417420 3700712418403 3700712418410 3700712409395 3700712408923 3700712417390 3700712416775 3700712416782 3700712412326 3700712408800 3700712417413 3700712416799 3700712416133 3700712412319 3700712408794 3700712417437 3700712419448 3700712418557 3700712409

UPC codes

03700712414207, 03700712407094, 03700712407087, 03700712407070, 03700712406141, 3700712407148, 3700712407155, 3700712407377, 3700712407384, 3700712407605, 3700712407612, 3700712407834, 3700712407841, 3700712406172, 3700712406288, 3700712406448, 3700712406479, 3700712406608, 3700712406615, 3700712406639, 3700712406660, 3700712416027, 3700712419820, 3700712408060, 3700712408336, 3700712411336, 3700712411596, 3700712406684, 3700712406967, 3700712406691, 3700712406882, 3700712416904, 3700712416966, 3700712417321, 3700712419424, 3700712418434, 3700712409722, 3700712409135, 3700712417352, 3700712418526

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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