RotoRest Delta Advanced Therapy System. The RotoRest recall: Labeling Error

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

SERIAL NUMBERS: RRHK00122, 00157053, RRHK00063, RRHK00123, 00157182, 00157217, 00157058, RRHK00060, 00157184, 00157346, RRHK00110, RRHK00119, 00157373, 00157027, 00157074, 00157220, 00157423, 00157088, 00157302, 00157365, RRHK00112, RRHK00001, RRHK00116, RRHK00003, 00157200, RRHK00014, 157030, 00157461, 00157464, 00157089, 00157304, 00157299, RRHK00121, 00157264, RRHK00071, RRHK00007, 00157243, 00157086, 00157432, RRHK00067, RRHK00097, 00157159, 00157258, 00157362, RRHK00118, RRHK00099, 00157230, RRHK00036, 00157471, 00157013, RRHK00015, 00157203, RRHK00005, 00157014, 00157358, 00157007, 00157344, 00157161, 00157426, RRHK00037, 00157295, 00157054, 00157308, 00157189, RRHK00069, 00157126, RRHK00098, 00157097, RRHK00006, RRHK00120, RRHK00102, RRHK00004, RRHK00101, 00157348, RRHK00107, 00157196, RRHK00066, RRHK00044, 00157303, RRHK00002, 00157305, 00157240, 00157194, 00157244, RRHK00016, 00157321, RRHK00093, 00157067, 00157123, 00157467, 00157465, 00157063, 00157398, 00157387, 00157388, 00157298, 00157313, 00157389, 00157233, 00157101, 00157363, 00157458, RRHK00068, RRHK00113, RRHK00040, 00157330, 00157404, 00157428, RRHK00009, 00157072, RRHK00034, RRHK00041, RRHK00086, RRHK00089, 00157412, 00157430, RRHK00026, 00157062, 00157134, 001P57000, 00157042, RRHK00072, 00157379, RRHK00088, 00157124, 00157232, 00157399, 00157413, RRHK00017, 00157107, 00157160, RRHK00038, 00157376, RRHK00035, RRHK00090, 00157076, 00157251, 00157384, 00157383, 00157129, 00157393, RRHK00031, RRHK00032, 00157094, 00157125, 00157152, 00157130, 00157287, 00157366, RRHK00020, 00157319, 00157445, 00157394, 00157474, RRHK00115, 00157249, 00157453, 00157163, 00157236, RRHK00022, RRHK00025, 00157108, 00157078, 00157135, RRHK00023, 00157335, 00157337, RRHK00024, 00157390, 00157357, RRHK00073, RRHK00018, RRHK00114, RRHK00076, RRHK00092, RRHK00033, RRHK00039, RRHK00027, RRHK00043, RRHK00094, RRHK00095, 00157425, RRHK00028, 00157452, 00157468, RRHK00011, RRHK00070, 00157043, 00157361, RRHK00091, 00157429, RRHK00056, RRHK00057, RRHK00062, 00157037, 00157102, 00157151, 00157153, RRHK00008, RRHK00104, RRHK00105, RRHK00124, 00157104, RRHK00046, RRHK00049, RRHK00051, 00157147, 00157224, RRHK00079, RRHK00083, RRHK00084, RRHK00082, 00157178, 00157214, 00157186, RRHK00080, RRHK00054, 00157262, 00157409, 00157222, 00157381, 00157434, RRHK00047, 00157442, RRHK00050, 00157378, 00157488, RRHK00048, RRHK00058, 00157447, RRHK00085, 00157132, 00157339, RRHK00064, RRHK00055, 00157171, 00157026, RRHK00108, RRHK00021, RRHK00019, 00157080, RRHK00029, RRHK00111, 00157261, 00157407, 00157414, 00157145, 00157149, 00157315, 00157355, 00157202, RRHK00042, 00157451, 00157172, 00157386, 00157060, 00157448, RRHK00077, 00157209, RRHK00061

Product

RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of…

Recalling firm

Arjo Hospital Equipment AB

Quantity

271 units

Distribution

Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.

Recall date

March 11, 2015

Classification

Class II

Status

Terminated

Agency

FDA (device)