Device product
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Z-2598-2025
Product summary
- Event
- Event 97468
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 210 units
- Official record key
device-enforcement:Z-2598-2025
Official wording
Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Code information: 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, 85118, 85127, 85142, 85147, 85144, 85196, 85233, 85265, 85180, 85173, 85202, 87013, 85189, 85200, 85243, 85211, 85221, 85217, 85215, 85236, 87004, 85249, 85276, 87015, 87037, 87031, 87045, 87211.
Distribution pattern: 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., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.
Derived failure modes
-
Unknown
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.