RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
Enforcement
- Recall Number
- Z-1216-2015
- Event ID
- 69970
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arjo Hospital Equipment AB
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 11, 2015
- Initiation Date
- December 3, 2014
- Classification Date
- February 27, 2015
- Termination Date
- October 30, 2015
- Address
- HANS MICHELSENSGATAN 10, N/A, Malm¿, N/A, N/A, Sweden
Description
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
The recalled devices labeling and instructions for use contain unapproved medical claims.
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
Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.
271 units