Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override panel.
Reason for recall: Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override panel. Distribution: Worldwide - US Nationwide distribution in the states of KY, NY, TX and the countries of Algeria, Australia, Austria, Bulgaria, Canada, China, Colombia, Denmark, Egypt, Estonia, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Lebanon, Morocco, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerlan Quantity: 315 units (8 US, 307 OUS) Lot/code info: Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; UDI-DI: (1) 04046768145177, (2) 04046768145184, (3) 04046768145191, (4) 04046768145207, (5) 04046768145214, (6) 04046768145221; Lot/Serial Numbers: (1) 1, 2, 3, 10, 25, 26, 27, 28, 22, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 24, (2) 9, 51, 53, 14, 15, 16, 17, 34, 35, 36, 37, 39, 40, 42, 43, 54, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 38, 44, 45, 46, 5, 13, 57, 58, 59, 18, 49, 47, 48, 7, 52, (3) 41, 5, 6, 45, 48, 49, 50, 23, 38, 10, 12, 13, 14, 84, 87, 88, 89, 7, 63, 80, 82, 83, 86, 54, 93, 94, 11, 15, 18, 20, 21, 22, 27, 28, 32, 40, 9, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 85, 55, 56, 57, 58, 59, 42, 97, 92, 17, 26, 16, 24, 25, 30, 33, 35, 36, 37, 39, 44, 53, 91, 8, 19, 90, 46, 47, 51, 52, 34, 43, 60, 62, 64, 65, 66, 67, 68, (4) 44, 70, 71, 42, 56, 65, 115, 185, 52, 105, 106, 107, 109, 145, 146, 147, 148, 11, 26, 19, 32, 33, 35, 36, 39, 53, 61, 63, 69, 14, 20, 68, 13, 18, 16, 101, 167, 170, 83, 3, 4, 23, 28, 37, 38, 40, 41, 43, 45, 47, 48, 50, 55, 58, 60, 62, 78, 81, 82, 92, 94, 96, 97, 98, 99, 100, 102, 116, 138, 139, 144, 150, 152, 153, 154, 155, 156, 165, 169, 171, 21, 22, 24, 25, 6, 17, 27, 29, 30, 34, 49, 51, 57, 64, 74, 75, 76, 77, 79, 80, 84, 85, 86, 87, 88, 89, 90, 91, 93, 95, 103, 104, 108, 110, 111, 112, 113, 114, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 140, 141,
04046768145177, 04046768145184, 04046768145191, 04046768145207, 04046768145214, 04046768145221
Official record: FDA (Device enforcement) ↗
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