Philips Healthcare IQon Spectral CT computed tomography x-ray system — Class II medical device recall Z-0333-2018
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2018-01-17. There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s
| Recall number | Z-0333-2018 |
|---|---|
| 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 | 2017-11-08 |
| Classified | 2018-01-11 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2020-04-17 |
| Countries outside the US | CA, MX |
| Quantity | 50 |
Product
Philips Healthcare IQon Spectral CT computed tomography x-ray system
Reason for recall
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
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-0333-2018. 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.