Arjo Hospital Equipment AB: Medical Device Recall in 2015 - (Recall #: Z-1216-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 3, 2014

Date Posted: March 11, 2015

Recall Number: Z-1216-2015

Event ID: 69970

Reason for Recall:

The recalled devices labeling and instructions for use contain unapproved medical claims.

Status: Terminated

Product Quantity: 271 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated