Incisive CT — Class II medical device recall Z-0881-2026
Ongoing recall by Philips North America Llc, reported 2025-12-10, distributed nationwide. If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This comp
| Recall number | Z-0881-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2025-10-29 |
| Classified | 2025-12-03 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, FR, GB, GR, HK, HR, HU, ID, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LT, LV, MA, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SK, SV, TH, TN, TT, TW, UA, VE, VN, ZA |
| Quantity | 2,341 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884838085015, 00884838105508, 55400406110738, 55400406111117, 55400406111438, 55400406111629, 55400406111636 |
| 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, 728144 |
Product
Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
Reason for recall
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
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-0881-2026. 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.