Incisive CT — Class II medical device recall Z-0640-2024
Ongoing recall by Philips Healthcare (Suzhou) Co., Ltd., reported 2024-01-17, distributed nationwide. Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect
| Recall number | Z-0640-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare (Suzhou) Co., Ltd., Suzhou, China |
| Recall initiated | 2022-12-23 |
| Classified | 2024-01-05 |
| Reported by FDA | 2024-01-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BG, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, FR, GB, GR, HK, HR, HU, ID, IL, IN, IQ, IT, JO, JP, KE, KR, LB, LT, LV, MA, MY, NL, NO, NZ, PA, PE, PH, PK, PL, PT, PY, RO, RS, RU, SA, SE, SK, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 828 |
| Reason classes | labeling, software |
| UPC / GTIN / UDI-DI | 00884838085015, 00884838105508 |
| Model numbers | 728143, 728144 |
Product
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Reason for recall
Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are too quiet, patient cant hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.
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-0640-2024. 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.