Home / Recalls / Philips North America / Z-2260-2023

Z-2260-2023 Class II Ongoing

Recalled by Philips North America — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
August 9, 2023
Initiation Date
April 25, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
53 units OUS

Product Description

Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148

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

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

Code Information

UDI-DI: (01)00884838103467 (21) Serial Numbers: 530456 530338 530360 530489 530370 530363 530389 530369 530481 530350 530464 530500 530436 530301 530501 530372 530466 530368 530476 530358 530294 530421 530435 530480 530458 530342 530432 530419 530460 530502 530349 530475 530482 530431 530335 530378 530494 530492 530470 530345 530461 530374 530384 530388 530357 530404 530329 530373 530409 530462 530420 530452 530307

Other recalls by Philips North America

  • Z-1315-2026 Class II — Brilliance iCT; Product Code (REF): 728306; (January 7, 2026)
  • Z-1318-2026 Class II — Spectral CT 7500 on Rails; Product Code (REF): 728334; (January 7, 2026)
  • Z-1317-2026 Class II — Spectral CT; Product Code (REF): 728333; (January 7, 2026)
  • Z-1316-2026 Class II — IQon Spectral CT; Product Code (REF): 728332; (January 7, 2026)
  • Z-1156-2026 Class II — Patient Information Center iX; Software Version Number: 4.5.0 (December 22, 2025)
  • Z-1033-2026 Class II — Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. (December 12, 2025)
  • Z-1210-2026 Class II — Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. M (December 3, 2025)
  • Z-1215-2026 Class II — SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with S (December 3, 2025)
  • Z-1208-2026 Class II — Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11. (December 3, 2025)
  • Z-1207-2026 Class II — Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW (December 3, 2025)