Z-2261-2023Class II

Incisive CT Plus-Computed Tomography X-Ray System Model: 728149

Name: Z-2261-2023 Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
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 Plus-Computed Tomography X-Ray System Model: 728149 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-2261-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-25
Posted: 2023-07-28
Recalling firm: Philips North America LLC
Product: Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
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: 6 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)00884838103474(21) Serial Numbers: 530408 530437 530474 530320 530332 530430

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2261-2023
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)