Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model:… — Class II medical device recall Z-2259-2023
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-2259-2023 |
|---|---|
| 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 |
| Quantity | 20 units |
| Reason classes | device malfunction |
| Serial numbers | 540000, 540001, 540002, 540003, 540004, 540005, 540006, 540007, 540008, 540009, 540010, 540011, 540012, 540013, 540014, 540015, 540016, 540017, 540018 |
| Model numbers | 728146 |
Product
Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
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-2259-2023. 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.