PHILIPS MEDICAL SYSTEMS: Spectral CT on Rails: Software Version 5.1.0.X, model 728334.

Hazard

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

Details from the source

Reason for recall: A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment. Distribution: Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand & United Kingdom. Quantity: US: 1 Lot/code info: UDI-DI: 00884838103627, serial number: 1005.

UPC codes

00884838103627

Source

Official record: FDA (Device enforcement) ↗

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