Z-1871-2024Class II

Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model...

Name: Z-1871-2024 Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model...
Creator: Philips North America Llc
Published: 2024-04-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2024-04-15 / Open, Classified

FDA source

Philips North America Llc began a recall of Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143 on 2024-04-15. FDA classified it as Class II and gives the reason as "Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1871-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-15
Posted: 2024-05-20
Recalling firm: Philips North America LLC
Product: Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
FDA root cause: Under Investigation by firm
Action: Philips issued URGENT Medical Device Correction Letter on 4/15/24 to US consignees. [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 FCO72800819 and FCO72800820). If you need additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in commerce: 18 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: UDI-DI: (01) 00884838085015 (21) + Serial number Serial Numbers- Applied to FCO72800819: 500046, 500064, 500074, 500102, 500110, 500111, 500145, 500168, 500178, 500211 500216, 500217, 500222, 500225, 500230, 500240, 500242. Serial Number-Applied to FCO72800820 : 500615

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1871-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1871-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-20
Z-1872-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-20

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)