Philips North America Llc: Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

Hazard

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Details from the source

Reason for recall: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Quantity: 210 units Lot/code info: 1. Model Number: 728306; UDI-DI: 00884838059474; Serial Number: 100068, 100188, 100241, 100288, 100332, 100365, 100461, 85007, 85016, 100657, 100682, 100686, 100779, 100832, 100783, 100775, 100788, 100807, 100828, 100816, 85136, 85153, 100043, 100038, 100082, 100074, 100081, 100097, 100098, 100119, 100111, 100113, 100123, 100130, 100133, 100222, 100141, 100134, 100160, 100157, 100150, 100158, 100180, 100161, 100173, 100215, 100064, 100117, 100247, 100172, 100196, 200045, 100191, 100374, 100189, 100230, 100203, 100201, 100204, 100211, 100234, 100227, 100249, 100285, 100245, 100253, 100226, 100264, 100292, 100268, 100294, 100302, 100315, 100301, 100310, 100336, 100314, 100349, 100354, 100321, 100389, 100385, 100446, 100424, 100401, 100352, 100404, 100511, 100412, 100438, 100435, 100455, 100380, 100487, 100429, 100427, 100443, 100393, 100413, 100462, 100604, 100456, 100497, 100498, 100502, 100500, 100445, 100510, 100505, 100513, 100635, 85018, 85014, 100612, 85041, 100603, 85035, 85028, 100669, 100622, 100627, 85065, 100631, 100601, 100663, 85053, 100656, 85062, 100708, 100685, 85057, 85061, 100677, 100653, 100673, 100707, 100672, 100691, 100683, 100678, 100687, 100718, 100717, 85069, 100698, 100695, 100704, 100769, 85058, 100712, 100711, 100744, 100800, 100735, 100734, 100727, 100745, 100851, 100763, 100766, 100770, 85104, 100780, 100784, 85129, 100840, 100794, 100797, 100815, 100829, 85087, 100809, 85082, 100821, 100814, 100836, 100834, 100837, 100831, 85121, 85124, 85169, 851

UPC codes

00884838059474

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.