PHILIPS HEADQUARTERS CAMBRIDGE: Medical Device Recall in 2023 - (Recall #: Z-1624-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: April 12, 2023
Date Posted: May 31, 2023
Recall Number: Z-1624-2023
Event ID: 92238
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

Status: Ongoing
Product Quantity: 1 unit
Code Information:

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

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

Voluntary or Mandated:

Voluntary: Firm initiated