RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
This recall has been terminated (originally issued February 27, 2015).
- Recall Initiated
- December 3, 2014
- Posted
- February 27, 2015
- Terminated
- October 30, 2015
- Recall Number
- Z-1216-2015
- Quantity
- 271 units
- Official Source
- View on FDA website ↗
Reason for Recall
The recalled devices labeling and instructions for use contain unapproved medical claims.
Distribution
Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.
Lot / Code Info
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
Root Cause
Labeling design
Action Taken
Devices in the rental fleet will be delivered to the customer with revised documents including the updated information. The customers who purchased the devices will be notified of the recall via letter sent by registered mail. The field correction notice will include a recall letter, response form, and updated labeling.