Infinix DP- i — Class II medical device recall Z-0360-2020
Terminated recall by Canon Medical System, USA, INC., reported 2019-11-20, distributed nationwide. Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short c
| Recall number | Z-0360-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2019-02-08 |
| Classified | 2019-11-12 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2022-06-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | NL |
| Quantity | 9 systems |
| Reason classes | device malfunction |
| Model numbers | 870B, D053991 |
Product
Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.
Reason for recall
Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.
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-0360-2020. 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.