Home / Recalls / PHILIPS HEADQUARTERS CAMBRIDGE / Z-1624-2023

Z-1624-2023 Class II Ongoing

Recalled by PHILIPS HEADQUARTERS CAMBRIDGE — Cambridge, MA

Recall Details

Product Type: Devices
Report Date: May 31, 2023
Initiation Date: April 12, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1 unit

Product Description

Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)

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 Pattern

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

Code Information

UDI-DI: (01)00884838103467 (21) Serial Number: 102342065