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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97970

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 19, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Canon Medical System, USA, INC.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

Alphenix INFX-8000C, interventional fluoroscopic x-ray system

Z-1176-2026
Recall number
Z-1176-2026
Initiated
December 19, 2025
Classification
Class II
Status
Ongoing
Quantity
172 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

serial numbers: W1C0632284, W4A1282279, W4A12Z2324, A2A2222381, A2A2392756, A3517001, A2A2352683, A2A2072087, A2A2072077, C1C2422647, W2A09Y2061, W2A10X2168, W4A11Y2144, A2A2232406, A2A2032038, W1D07Z2458, W2A09X2053, B2B1812645, A1C19Z2182, W4B1332362, B2A1622324, W4C1352385, W4A1292284, A1C19X2152, A1C1942058, A1C1972104, B2A1592233, B2A1792598, W2A1012081, W2A1052121, W4C1342374, B2B1872766, A4562105, W2A0972027, A1C2052199, A2A21X2339, W2A1012082, W4C1342369, W1D07Z2449, A1C1942065, A2A2132228, A2A2172285, A2A2117001, W1D06Z2357, A2A2282477, A2A2232405, W1B08X2034, A2A2182313, W4A1232210, A2A2262452, B2A16X2449, B2B1862743, B2B1872751, W1D0697014, W1C05X2229, B2A1542162, A2A21Z2364, A2A2392751, B2A1722527, A2A22Z2566, B4582115, W4C1372400, A2A2362690, A2A2252436, A2A2292510, B2A1582209, B2A1472014, W1D0732376, A2A2252439, W1D0732374, A1C1972105, A1C1972112, B4602126, W1B08Z2063, A2A2152265, A2A2132230, A2A2282491, A2A2262445, A2A22Y2550, A2A22X2528, W4A1212180, W4A1212176, W4A1212177, A1C1992141, W4A1182110, W4A11Z2163, W1D0812466, B2B18Y2816, B2B1832693, A1C1952078, A2A2062070, W2A09Z2077, A1C19Y2174, W1D0722372, A2A22X2518, A3542008, B2A1472020, W4A1242224, W4A1312348, A2A2172280, W4D1422466, W4A1142069, A2A2172287, A2A2342657, A2A2432872, B2A1552176, B2B1812657, B2B1872765, W4A1342373, B2A1682407, W4A11Z2170, W4C1342364, W4C1342365, W4A1172092, A2A2172281, W2A1072143, W4A1292281, A2A2242426, A2A2392761, A3612061, A1A2162240, A2A23Z2814, B2B1872760, A2A2262456, A1C2042197, B2A14Z2085, W4C1352377, W4A1252245, A1C19Z2178, A2A2292499, W4A1242221, W1D0872524, A1C19Z2188, A1C19X2158, A2A2052053, B2B1862731, B2A1752550, B2B1832678, B2B1852708, B2B1852710, B2B1852707, W1C0582207, W1C05Y2242, W1D0722370, W4A1272267, W2A1062127, B2A1742539, B2B1922842, A2A2062066, B2A16Y2469, W4A1122048, B2A1662369, W4A1122039, B5512160, A2A2122205, B2B1822664, B2B1822670, A2A2292498, W4D13Y2442, A2A2122197, A2A2192330, A2A2132216, A2A22X2522, A2A2432885, A2A2422855, W2A1012091, W1C05X2224, B2A1622310, A1C1972111, B2B1892787, A1C1952080, A1B18Y7002.

Distribution pattern

Worldwide distribution - US Nationwide and the country of Dominican Republic.

device · product 2 of 4

Alphenix INFX-8000F, interventional fluoroscopic x-ray system

Z-1177-2026
Recall number
Z-1177-2026
Initiated
December 19, 2025
Classification
Class II
Status
Ongoing
Quantity
98 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

Worldwide distribution - US Nationwide and the country of Dominican Republic.

device · product 3 of 4

Alphenix INFX-8000H, interventional fluoroscopic x-ray system

Z-1178-2026
Recall number
Z-1178-2026
Initiated
December 19, 2025
Classification
Class II
Status
Ongoing
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

serial numbers: D2A1672385, A2A20Z2165, B2A1692426.

Distribution pattern

Worldwide distribution - US Nationwide and the country of Dominican Republic.

device · product 4 of 4

Alphenix INFX-8000V, interventional fluoroscopic x-ray system

Z-1179-2026
Recall number
Z-1179-2026
Initiated
December 19, 2025
Classification
Class II
Status
Ongoing
Quantity
332 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

serial numbers: B2A1522117, E0514103, B2A15X2238, B2A1792589, A2A2242418, A2A21X2345, B2A1692413, A2A2152263, A2A2262450, A2A22Z2576, W4A1252250, A2A20Z2167, W4A10X2001, A2A2412831, W1C0552181, W1D0842501, W4D13Z2452, W4A1322350, W4D1422467, B2A1472002, A1C1982123, W2A1062134, W1B08X2042, W2A1072139, W4A1242220, A2A2382741, B2A17Z2627, A2A2152264, W4C1362387, W4D1422465, D4W1262257, W1D0892543, W4D1462478, W4A1182118, W4A11X2133, W4A11Z2167, N/A Deinstalled, A1B18Z7003, W4A1252243, DFP800A-0001, A3552017, W2A1092165, W1D0882537, A2A2122203, W4A10Z2022, W4B1332361, A2A23Y2788, W4A12Z2328, B2A1662374, W4A12Z2329, B2A1622309, B2A14X2056, A2A2272459, A2A2172291, W4A1132061, W1D0832488, W1D0882536, W2A0962022, W2A0982038, W2A0972026, B2A1642351, A2A2152255, W1D0752392, A2A2182308, A2A2412836, A2A2112189, A2A21X2336, A1C19Y2164, A1C1942056, A2A2192328, A2A2332643, W4C1372398, A2A22Y2553, A2A2132226, W4A1262256, B2A1472013, W2A1022097, W2A1022094, W4A10Z2017, W1B08Y2055, B2A1492051, B2A1492052, W4A10Z2021, W4A12Z2332, W4D1412463, W4A1122040, B2B1862727, B2B1812651, B2A1662376, B2A16X2448, B2A1742547, W4A1242230, W4A1272271, G3514035, B2A17X2601, W1D07Z2454, W4A1272272, A2A2142238, B2B1862746, B2B18X2800, A2A2022014, A2A2032029, A2A2172288, A2A2122199, A2A2152258, A2A2012004, W4A10X2004, B2B18X2810, B2B1952847, A2A2142244, A2A2172297, W2A0992045, W4A1262253, W4A1282278, W4A12Z2330, W4A1312340, W2A09Z2075, B2A1652363, W4A1272266, W4A1162079, A2A2152253, W2A1092160, W4D1452476, W1D07Y2445, W2A1072147, A1C1962090, A1C1962089, B2A1652362, W4D14Y2481, A2A20Z2157, A2A22Y2547, A2A2162266, W4A1212183, W4A1212189, W4A1212190, W4A11Z2172, W4A1212178, W4A1212191, W4A1212185, W4A1212184, W4A1132060, W4A1242222, B2A1612295, B2A16Y2468, W4A1222003, A4512077, W2A0982043, W1D0892547, W2A0972030, W2A1042109, A2A2322602, W2A1047001, A1C1982121, A2A2332647, B2A16Y2455, B2A16Y2456, B2A17X2608, B2A17X2605, B2A17X2607, B2A1592231, A2A2232398, B2B1822666, W1B08Z2064, W1B08Z2067, A1C1942063, A1B1922042, B2B1842698, B2B1882777, B2B1892792, W4A1162083, A1C1962094, W4A1222202, W4A12X2299, B2A15X2243, A2A20Y2153, W2A1072141, W4A10Z2014, W4A1142064, W4A1252239, W2A1062136, A2A21X2344, W1D0697017, A2A2022026, A2A22Z2572, W1D0882538, A2A2142237, A2A20Z2161, A1C1992148, W4A1252241, B2A16X2454, W4A1242223, W4A1162089, A2A2242410, B2A1622320, W1D0812470, A2A2182307, A2A2332638, W4A1272240, B2A16Y2474, A2A2262444, A1C1952074, B2A1612300, W4A10Y2006, B2A1582203, W4A1242231, W4A12X2300, B2A1522121, B2A1532152, A2A2142245, B2A1512107, W4D1452473, A1C1992135, A2A2132229, A2A2092109, A2A2052055, A2A2142241, W2A09Y2065, A2A2062064, A2A21X2347, W4C1382414, B2A16Z2492, B2B1582210, B2A14X2062, B2A14Z2097, B2B1882769, W2A0962024, W4A1272261, W2A1052126, W2A09Y2064, B2A1622321, W4A10Z2018, W4A1262254, W4A1182121, W4C13X2433, W4C13X2432, W4C1372401, W1C0632285, A2A2282476, W4C1362389, W4A1322353, B2A15Y2252, W2A1042114, W2A1052125, W2A1072142, W4A1312343, W4A1142063, W4C1362388, W4C1352376, W4C1352378, B2B1862733, A1C1962097, B2B2032825, B2A1592224, A1C1962088, W1B08X2026, W1D0872529, W1D0732379, B2B1872763, B2A17Z2630, B2A17Z2629, W4A11X2132, W4A1112033, F1514114, W4A1122043, W4A1242237, W1D0697015, W1B08X2036, A2A2132227, W1B08Y2050, W4A1112035, W2A09Z2078, A2A2292515, A2A2422852, B2A1582215, W4A1272262, A1C1942064, W4C1342371, A1C19X2155, W4A1212186, W4A1212175, A2A2072088, B2A16Y2467, B2A1612293, B2B18Z2830, B2B1812654, W4A11Z2169, W4A1222196, W4A1212174, W1D0862519, W4A1217002, W4A1242225, B2A14X2057, A2A2432873, W1D0892545, A2A2232396, A2A2382740, W4D1452474, B2A17Z2634, B2B1842701, W2A1072145, F9624025, B2A1532147, A2A2262447, A2A2142246, B2A14Z2099, A2A2152262, B2B1832680, A2A2242429, W1D0782416, B2B1862728, B2B1862735, B2A1642352, B2A16Z2480, W4A1312344, A2A2082098, W2A0982041, B2A1772578, A2A2092106, W4A1162085, B2B1832692, A2A2142236, B2A1552177, A1B1932051, A1B1932049, B2A1682401, W4A12Z2323, B2A1712502, B2A17X2604, W4A12Y2316, B2A1712504, B2A1512106, A2A20X2083.

Distribution pattern

Worldwide distribution - US Nationwide and the country of Dominican Republic.