Philips North America Llc: Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

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: 81 units Lot/code info: 1. Model Number: 728332; UDI-DI: 00884838059542; Serial Numbers: 860088, 860023, 860077, 860086, 60019, 860152, 860215, 60031, 60123, 60129, 60152, 860011, 860049, 860019, 860008, 860030, 860025, 860009, 860022, 860013, 860024, 860020, 860036, 860041, 860046, 860055, 860058, 860054, 860073, 860065, 860070, 860072, 860066, 860103, 860076, 860085, 860095, 860102, 860101, 860104, 860175, 860136, 860117, 860120, 860121, 860124, 860125, 860191, 860131, 860150, 860164, 60041, 860207, 60003, 860157, 860167, 860158, 860196, 60012, 860176, 860185, 860168, 860179, 860194, 60010, 60013, 60007, 60001, 395003, 860209, 860208, 60036, 60030, 60027, 60054, 60055, 60053, 60058, 60079, 395005, 60145.

UPC codes

00884838059542

Source

Official record: FDA (Device enforcement) ↗

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