iCT — Class II medical device recall Z-2189-2019
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2019-08-14, distributed nationwide. In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, image
| Recall number | Z-2189-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2019-06-24 |
| Classified | 2019-08-06 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2022-10-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GY, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KE, KR, KW, KY, LB, LK, LT, LU, LV, MA, MT, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 128 |
| Reason classes | labeling |
| Serial numbers | 10015, 7638, 8306, 85000 |
| Model numbers | 728306 |
Product
iCT, Model # 728306, computed tomography x-ray system
Reason for recall
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
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-2189-2019. 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.