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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74731

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

Open FDA event record

Event summary

Timeline bucket
July 19, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Electronics North America Corporation

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

3 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 3

MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.

Z-2305-2016
Recall number
Z-2305-2016
Initiated
July 19, 2016
Classification
Class II
Status
Terminated
Quantity
993 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag

Code information

All serial numbers. 708034 System serial numbers 6, 264, 112, 106, 233, 136, 31, 83, 224, 144, 71, 123, 5, 249, 134, 103, 266, 97, 132, 61, 19, 82, 196, 3, 12, 39, 244, 197, 119, 204, 75, 151, 69, 70, 37, 115, 55, 200, 180, 175, 78, 93, 234, 130, 142, 53, 113, 65, 27, 242, 202, 14, 208, 247, 261, 225, 28, 11, 110, 25, 128, 171, 81, 237, 211, 54, 76, 163, 207, 216, 122, 135, 205, 63, 238, 254, 262, 72, 1, 206, 187, 52, 143, 154, 155, 156, 73, 150, 98, 248, 80, 22, 133, 209, 167, 265, 105, 217, 79, NTS0427, 129, 13, 15, 16, 17, 18, 24, 84, 146, 41, 190, 10, 194, 125, 268, 177, 109, 42, 43, 44, 172, 213, 181, 212, 189, 26, 95, 9, 4, 117, 251, 2, 48, 183, 157, 245, 116, 62, 56, 160, 152, 127, 94, 174, 176, 259, 50, 58, 51, 277, 68, 159, 77, 40, 199, 253, 114 257, 246, 23, 147, 162, 29, 66, 47, 179, 221, 126, 195, 220, 161, 46, 182, 278, 138, 222, 269, 36, 96, 201, 137, 223, 228, 219, 60, 272, 111, 35, 85, 186, 38, 120, 170, 185, 32, 64, 30, 100, 101, 104, 235, 34, 148, 149, 67, 118, 121, 241, 210, 191, 255, 168, 273, 33, 240, 131, 88, 8, 193. 708037 System Serial numbers 48, 85, 17, 53, 2, 125, 170, 180, 157, 33, 49, 200, 18, 84, 216, 36, 116, 234, 201, 135, 236, 39, 96, 34, 19, 54, 132, 5, 154, 83, 151, 29, 21, 110, 175, 228, 183, 20, 4, 91, 69, 44, 205, 89, 164, 240, 165, 13, 51, 121, 174, 120, 43, 160, 185, 171, 23, 209, 95, 144, 50, 141, 156, 80, 94, 150, 190, 41, 10, 113, 93, 98, 196, 38, 64, 86, 72, 73, 230, 56, 22, 140, 181, 192, 37, 12, 191, 195, 155, 221, 182, 133, 246, 149, 169, 61, 62, 100, 101, 102, 103, 219, 226, 227, 46, 97, 99, 55, 3, 7, 8, 63, 233, 106, 114, 206, 207, 108, 213, 32, 163, 24, 92, 176, 212, 179, 14, 193, 214, 6, 30, 173, 222, 146, 115, 90, 177, 59, 25, 189, 118, 218, 153, 107, 161, 31, 27, 112, 42, 104 76, 26, 217, 35, 124, 139, 15, 66, 241, 245, 40, 239, 123, 58, 88, 172, 129, 81, 136, 159, 244, 238, 82, 65, 249, 70, 142, 188, 178, 158, 128, 117, 148, 45, 203, 79, 229, 199, 119, 126, 152, 71, 52, 60, 197, 198, 87, 105. 708038 System serial numbers 158, 146, 196, 164, 37, 63, 213, 209, 218, 252, 255, 256, 7, 96, 170, 45, 173, 100, 51, 155, 83, 210, 90, 212, 159, 217, 226, 1, 53, 181, 163, 140, 47, 95, 148, 39, 26, 10, 114, 108, 71, 141, 115, 61, 16, 42, 33, 14, 36, 106, 112, 35, 137, 48, 60, 157, 25, 50, 54, 156, 116, 12, 68, 105, 3, 11, 161, 204, 205, 15, 232, 9, 220, 109, 227, 224, 201, 250, 251, 91, 92, 93, 207, 72, 228, 171, 118, 57, 189, 132, 129, 216, 138, 29, 24, 31, 2, 119, 139, 5, 28, 49, 22, 23, 208, 80, 98, 30, 125, 193, 167, 168, 169, 75, 81, 131, 221, 211, 41, 160, 192, 43, 44, 154, 97, 6, 219, 8, 79, 135, 88 107, 65, 194, 126, 69, 247, 248, 249, 13, 215, 78, 243, 245, 246, 175, 38, 177, 253, 191, 32, 259, 235, 264, 258, 52, 67, 111, 257, 94, 142, 143, 260, 121, 236, 268, 265, 74, 101, 182, 174, 124, 239, 4, 172, 263, 254, 149, 151, 64, 183, 184, 76, 152, 188, 261, 242, 244, 34, 162, 147, 241, 134, 178, 237, 176.

Distribution pattern

Worldwide distribution. US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, TURKEY, Ukraine, United Arab Emirates, and United Kingdom.

device · product 2 of 3

UroDiagnost; x-ray system. Product Code: 708033

Z-2306-2016
Recall number
Z-2306-2016
Initiated
July 19, 2016
Classification
Class II
Status
Terminated
Quantity
993 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag

Code information

All serial numbers. 708033 System serial numbers 1, 17, 15, 4, 3, 7, 18, 21, 8, 13, 14, 11, 5, 16, 2.

Distribution pattern

Worldwide distribution. US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, TURKEY, Ukraine, United Arab Emirates, and United Kingdom.

device · product 3 of 3

MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036

Z-2307-2016
Recall number
Z-2307-2016
Initiated
July 19, 2016
Classification
Class II
Status
Terminated
Quantity
993 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag

Code information

All serial numbers. 708032 System Serial numbers 100, 198, 354, 104, 367, 68, 428, 183, 414, 355, 289, 32, 269, 361, 160, 423, 50, 56, 205, 350, 71, 208, 254, 108, 222, 286, 257, 253, 327, 128, 125, 40, 265, 174, 164, 214, 411, 263, 178, 103, 394, 425, 374, 284, 229, 79, 37, 11, 312, 116, 226, 296, 44, 49, 219, 207, 227, 154, 317, 18, 87, 406, 88, 244, 233, 315, 376, 288, 112, 402, 206, 261, 215, 31, 422, 344, 338, 342, 339, 384, 12, 136, 415, 416, 137, 228, 46, 126, 276, 280, 51, 193, 54, 232, 140, 20, 270, 121, 25, 59, 60, 48, 21, 28, 196, 199, 380, 316, 159, 153, 172, 14, 62, 216, 75, 282, 294, 340, 102, 76, 64, 13, 231, 106, 305, 372, 366, 364, 77, 189, 24, 279, 166, 221, 349, 72, 42, 424, 0, 80, 217, 43, 213, 197, 413, 145, 318, 210, 341, 111, 343, 55, 292, 241, 151, 246, 0, 110, 29, 141, 362, 35, 143, 236, 278, 99, 133, 365, 85, 267, 132, 134, 163, 127, 266, 412, 142, 144, 293, 358, 399, 303, 308, 238, 239, 287, 243, 74, 310, 34, 345, 39, 69, 409, 162, 240, 281, 368, 382, 357, 277, 26, 165, 224, 170, 171, 392, 237, 119, 30, 396, 36, 38, 211, 255, 53, 146, 188, 404, 41, 81, 256, 16, 130, 184, 115, 107, 247, 275, 373, 169, 192, 248, 388, 389, 147, 352, 397, 417, 209, 98, 245, 92, 203, 314, 297, 290, 353, 383, 86, 309, 363, 251, 235, 379, 129, 225, 260, 405, 90, 84, 249, 139, 120, 329, 161, 218, 201, 347, 66, 283, 122, 33, 113, 114, 268, 180, 181, 182, 105, 298, 299, 109, 124, 295, 258, 194, 73, 57, 91, 369, 259, 403, 152, 138, 400, 93, 157, 118, 89, 15, 220, 212, 401, 61, 67, 135, 47, 148, 65, 264, 346, 173, 407, 123, 375, 291, 52, 393, 306, 307, 398, 190. 708036 System serial numbers 19, 40, 21, 8, 9, 16, 45, 11, 17, 14, 30, 31, 32, 48, 12, 50, 4, 15, 25, 13, 18, 42, 46, 41, 36, 35, 37, 47, 27, 43, 10, 5, 7, 24, 34, 29, 26.

Distribution pattern

Worldwide distribution. US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, TURKEY, Ukraine, United Arab Emirates, and United Kingdom.