Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F… — Class II medical device recall Z-1271-2021
Ongoing recall by Canon Medical System, USA, INC., reported 2021-03-24, distributed nationwide. System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit m
| Recall number | Z-1271-2021 |
|---|---|
| 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 | 2020-12-08 |
| Classified | 2021-03-17 |
| Reported by FDA | 2021-03-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, JP, KR, SG |
| Quantity | 145 systems |
| Serial numbers | 99A1337005, 99C1482200, 99C14Z2224, 99E1582258, 99E1592262, 99E15Y2271, 99E1612286, 99E1662308, 99E1712345, 99E1712347, 99E1762365, 99F1852401, 99F1862406, 99F18Y2428, 99G1972436, 99G19Z2438, AHA1482001, AHA14Z2002, AHA1582003, AHA1592004, AHA15Y2005, AHA1612006, AHB1662007, AHB1712008, AHB1712009 and 7 more |
| Model numbers | 880B, INFX-8000F, INFX-8000F/AH, INFX-8000F/BH, INFX-8000F/BHUP, INFX-8000F/UU |
Product
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.
Reason for recall
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
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-1271-2021. 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.