Philips North America Llc: Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model

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: 33 units Lot/code info: 1. Model Number: 728242; UDI-DI: 00884838095168; Serial Number: 766018. 2. Model Number: 728243; UDI-DI: N/A; Serial Numbers: 7179, 7238, 7273, 7418, 7467, 7608, 7634, 7618, 7801, 7925, 75111, 75045, 75119, 75035, 75132, 750019, 76023. 3. Model Number: 728244; UDI-DI: 00884838059450; Serial Numbers: 7271, 7979, 76234, 750003, 7878, 76054, 760019, 76135, 76230, 76147, 76171, 760057, 760058, 76270, 760075.

UPC codes

00884838095168, 00884838059450

Source

Official record: FDA (Device enforcement) ↗

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