Philips North America Llc: Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 72832

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: 285 units Lot/code info: 1. Model Number: 728321; UDI-DI: 00884838059498; Serial Numbers: 310033, 310095, 310098, 333020, 333135, 52084, 310005, 310019, 310030, 310038, 310050, 310057, 310053, 310075, 310126, 310009, 310101, 310108, 310157, 310170, 333024, 310171, 333061, 333021, 52007, 52017, 52039, 333053, 31001, 333130, 52025, 52037, 52056, 333132, 52063, 333077, 310288, 310230, 310221, 310238, 310294, 310286, 310233, 310259, 310283, 310293, 310262, 310274, 333092, 333107, 310317, 333131, 333118, 333124, 333151, 310326, 310323, 310340, 333153, 310356, 310382, 310378, 333166, 333179, 310397, 52103, 333193, 52121, 52122, 52157, 52161, 52153, 68106, 52194, 40009. 2. Model Number: 728323; UDI-DI: 00884838059504; Serial Numbers: 30016, 320084, 320099, 336069, 336118, 336107, 320271, 336237, 336769, 320439, 32291, 336447, 32358, 68164, 40085, 40075, 320008, 320037, 320019, 320017, 320071, 320042, 320055, 320101, 320108, 320104, 320117, 336056, 320122, 32058, 320129, 333019, 336030, 32016, 336028, 320070, 32003, 32004, 32014, 336070, 32010, 336033, 32089, 32072, 32048, 336067, 32076, 32061, 32046, 320233, 336076, 32094, 32001, 32065, 32130, 320322, 336708, 32084, 32105, 32103, 32096, 336704, 336130, 32118, 336108, 32143, 336115, 336129, 32135, 336109, 336113, 32136, 32137, 320251, 336735, 32028, 336114, 336158, 320258, 32163, 336175, 32149, 320284, 320270, 336784, 336767, 336762, 336770, 336177, 336754, 336768, 336774, 336781, 336246, 336758, 320278, 320356, 320363, 336772, 336259, 320281, 32169, 336785,

UPC codes

00884838059498, 00884838059504, 00884838059511

Source

Official record: FDA (Device enforcement) ↗

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