Recall archive / FDA device enforcement
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, IN... — FDA record Z-0492-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 20, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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.
- Classification
- Class II
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 8
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0492-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | SID: 30039059, Alphenix System Serial Number: BGC20Y2010, & Flat Panel Detector Serial Number: C1B20Y2215 SID: 30030612, Alphenix System Serial Number: B8D20Z2001, & Flat Panel Detector Serial Number: C1B20Z2218; SID: 30030612, Alphenix System Serial Number: B8D20Z2001, & Flat Panel Detector Serial Number: C1B20Z2219; SID: 30046247, Alphenix System Serial Number: B1B20Z2001, & Flat Panel Detector Serial Number: C1B20Z2221; SID: 30064041, Alphenix System Serial Number: BGD2172011, & Flat Panel Detector Serial Number: C1B2172234; SID: 30065145, Alphenix System Serial Number: B1E2172002, & Flat Panel Detector Serial Number: C1B2172235; SID: 30058149, Alphenix System Serial Number: B1E2152001, & Flat Panel Detector Serial Number: C1B2152230; SID: 30002089, Alphenix System Serial Number: BHC20Z2003, & Flat Panel Detector Serial Number: C1B20Z2217. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 19, 2022
- Recall initiation date
- Dec 20, 2021
- Center classification date
- Jan 12, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.