PHILIPS HEADQUARTERS CAMBRIDGE: Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)

Hazard

Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

Details from the source

Reason for recall: Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required Distribution: AR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia Czech Republic Dominican Rep France Germany Guadeloupe Hong Kong India Japan Kuwait Latvia Lithuania Netherlands Norway Portugal Romania Spain Switzerland Taiwan Thailand United Kingdom Vietnam Quantity: 5 units Lot/code info: UDI-DI: (01)00884838103474(21) Serial Number: 530537 554032 554060 554065 554078

UPC codes

00884838103474

Source

Official record: FDA (Device enforcement) ↗

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