CAS-930A Flat Panel Monitor — Class II medical device recall Z-0532-2021
Terminated recall by Canon Medical System, USA, INC., reported 2020-12-09, distributed nationwide. There is a potential that the cable of the Flat panel detector may break during a procedure which may cause th
| Recall number | Z-0532-2021 |
|---|---|
| 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 | 2020-10-08 |
| Classified | 2020-12-03 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2022-12-06 |
| Distributed | Nationwide (US) |
| Quantity | 14 units |
| Reason classes | device malfunction |
| Serial numbers | AEA17X2001, AEB1812002, AFA1662001, AFA1692002, AFB1832003, AFB1872004, AFB1872005, AFB1892006, AFB1892007, BEC2032001, BFA18Y7001, BFA1932001, BFB1942002, BFB1952003, BFB1972004, BFB1972005, BFC2012006, BFC2062007, BFC2062008, BHA1992001 |
| Model numbers | INFINIX-8000C, INFINIX-8000H |
Product
CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - 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
There is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is completed. This could result in a delay with procedure and/or potential damage to the patients blood vessels due to removal without visibility.
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-0532-2021. 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.