Infinix-8000F with Catheterization Table CAT-850B or CAT-860B — Class II medical device recall Z-2327-2020
Ongoing recall by Canon Medical System, USA, INC., reported 2020-06-17, distributed nationwide. Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surfac
| Recall number | Z-2327-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2020-03-03 |
| Classified | 2020-06-09 |
| Reported by FDA | 2020-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 15 |
| Serial numbers | A5C1922001, AGA1492002, AGA1552003, AGB1482001, AGB1682004, AGB1692005, AGB16Z2006, AGB1712007, AGB17Y2009, AGB17Z2010, AGC1822011, AGC1822012, AGC18X2013, AGC1952014, BGB1992001 |
| Model numbers | 850B, 860B |
Product
Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Reason for recall
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
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-2327-2020. 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.