Incisive CT-Computed Tomography X-Ray System Model: 728143 — Class II medical device recall Z-2258-2023

Ongoing recall by Philips North America, reported 2023-08-09, distributed nationwide. Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system

Recall number	`Z-2258-2023`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Philips North America, Cambridge, MA, United States
Recall initiated	2023-04-25
Classified	2023-07-28
Reported by FDA	2023-08-09
Distributed	Nationwide (US)
Countries outside the US	AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CL, CN, CO, CZ, DE, DZ, EC, EG, ES, FR, GB, GR, ID, IL, IN, IQ, IR, IT, JO, JP, KR, LV, MX, NG, NL, PA, PH, PK, PL, RO, RS, SA, SE, SK, TH, TN, TR, TW, VN
Reason classes	device malfunction
UPC / GTIN / UDI-DI	`00884838085015`
Serial numbers	`33001`, `33002`, `33003`, `33005`, `33006`, `33007`, `33008`, `33009`, `33010`, `33011`, `33012`, `33013`, `33015`, `33016`, `33017`, `33018`, `33019`, `33020`, `33021`, `33022`, `33023`, `33024`, `33025`, `33026`, `33027` and 475 more
Model numbers	`728143`

Product

Incisive CT-Computed Tomography X-Ray System Model: 728143

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2258-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.