Flat Panel Detector — Class II medical device recall Z-0492-2022
Ongoing recall by Canon Medical System, USA, INC., reported 2022-01-19, distributed nationwide. Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting
| Recall number | Z-0492-2022 |
|---|---|
| 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 | 2021-12-20 |
| Classified | 2022-01-12 |
| Reported by FDA | 2022-01-19 |
| Distributed | Nationwide (US) |
| Quantity | 8 |
| Serial numbers | 30002089, 30030612, 30046247, 30058149, 30064041, 30065145, B1B20Z2001, B1E2152001, B1E2172002, B8D20Z2001, BGC20Y2010, BGD2172011, BHC20Z2003, C1B20Y2215, C1B20Z2217, C1B20Z2218, C1B20Z2219, C1B20Z2221, C1B2152230, C1B2172234, C1B2172235 |
| Model numbers | INFX-8000C, INFX-8000F, INFX-8000H, INFX-8000V, TFP-800A |
Product
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Reason for recall
Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a catheter from the patient's blood vessel and damage the blood vessel.
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-0492-2022. 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.