Recall archive / FDA device enforcement
Alphenix INFX-8000F, interventional fluoroscopic x-ray system — FDA record Z-1177-2026
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 19, 2025. 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
- Alphenix INFX-8000F, interventional fluoroscopic x-ray system
- Reason
- It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
- Classification
- Class II
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 98 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1177-2026
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 | serial numbers: W1C0582204, B2A1582208, W2A1052118, A3582035, A2A2362689, B2B18Y2813, W1D07Y2447, B4582113, W2A1042111, W1C0622270, A3592048, W4A11X2138, W2A09Y2060, B2A16Z2476, W2A09Y2066, W4A1122041, B2A1482032, B2A1482027, A2A2252435, W1D0722369, B2B15Y2247, W1B0542168, B2A1492049, W1D0722371, A2A2032031, A1C1972103, W4C1352375, B2B1862737, W1D0842499, W4A1212179, W4A11Z2171, W4A11Z2173, W1C0652298, B2A1692419, B2A1552170, A2A21Y2350, W4A1242226, B2B1952848, A1C19Z2180, B2A1662371, W1D0892555, W1D0822476, W1D06Z2356, B2A1682394, B2A17Y2619, B2A17Y2624, W1D0762406, A2A2172283, W4A11Y2155, A2A2272460, W1D0832487, B2B1822667, A1C1992146, W4A1112031, W4C1382409, A2A2292508, W4A13X2015, W4A1192130, B2A1712510, B2A1762562, W4A1142066, W1C0622274, A4552098, W4A12X2298, W1D0812460, A4542088, W1D0712363, A2A21X2348, W1C0552179, W4A1142065, B2A17Z2626, W4D13Y2444, W2A1042110, A2A20Z2159, W4A11Y2147, W1C0642289, B2B1852720, B2A1592219, W4B13Y2016, B2B1922843, B2B1822668, W4B12Y2312, A2A2052056, A2A2062062, A2A2072075, A2A2042041, A1C19Z2181, W2A1092163, A2A2012005, A2A20Y2147, A1C19Y2161, B2A1612289, W4A1112030, W2A0982042, B2B18X2802, B2A1712503, B2A1712499, B2A14Z2084. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the country of Dominican Republic.
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
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- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
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- Wyoming
Dates in the source
- Report date
- Feb 4, 2026
- Recall initiation date
- Dec 19, 2025
- Center classification date
- Jan 27, 2026
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.