Philips North America: Medical Device Recall in 2023 - (Recall #: Z-2261-2023)

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 Plus-Computed Tomography X-Ray System Model: 728149

Product Classification:

Class II

Date Initiated: April 25, 2023

Date Posted: August 9, 2023

Recall Number: Z-2261-2023

Event ID: 92202

Reason for Recall:

Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down

Status: Ongoing

Product Quantity: 6 units OUS

Code Information:

UDI-DI: (01)00884838103474(21) Serial Numbers: 530408 530437 530474 530320 530332 530430

Distribution Pattern:

Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France Germany Greece India Indonesia Iran Iraq Israel Italy Japan Jordan Korea, Republic of Kosovo Latvia Macedonia Mexico Moldova Netherlands Nigeria Pakistan Panama Philippines Poland Romania Russian Federation Saint Lucia Saint Pierre and Miquelon Saudi Arabia Serbia Slovakia Spain Sweden Taiwan Thailand Tunisia Turkey Turkmenistan United Kingdom Uzbekistan Viet Nam

Voluntary or Mandated:

Voluntary: Firm initiated