Z-2260-2023Class II

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

Name: Z-2260-2023 Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
Creator: Philips North America
Published: 2023-04-25
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-04-25 / Open, Classified

FDA source

Philips North America began a recall of Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148 on 2023-04-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2260-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-25
Posted: 2023-07-28
Recalling firm: Philips North America LLC
Product: Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
Product code: JAK System, X-Ray, Tomography, Computed
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
FDA root cause: Under Investigation by firm
Action: Phiips issued Urgent Medical Device Correction Letters mailed to US consignees via Certified United States Postal Service (USPS) with delivery confirmation on 4/25/23 International global markets were notified of the issue and instructed to distribute the FSN to affected consignees in accordance with local requirements. Letter states reason for recall, health risk and action to take: Please continue to use your system in accordance with its intended use. If you need to remain in the room for the duration of a scan, Philips recommends using protective eyewear. " Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. " Place this URGENT Medical Device Correction Letter with your system documentation. " Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. Philips will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site and install a solution to address the issue (reference FCO72800798). If you need additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in commerce: 53 units OUS
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2260-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2258-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28
Z-2259-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28
Z-2260-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28
Z-2261-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28

Product code JAK

K180015Class IIPhilips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. / cleared 2018-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)