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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76806

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 20, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
AGFA Healthcare Corp.

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

1 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 1

AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis

Z-1698-2017
Recall number
Z-1698-2017
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Recalling firm
AGFA Healthcare Corp.
Quantity
308

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.

Code information

A5410000053, A5410000054, A5411000439, A5411000446, A5411000447, A5411000448, A5410000067, A5410000068, A5410000069, A5410000070, A5410000072, A5410000073, A5410000100, A5410000107, A5410000134, A5411000184, A5410000039, A5411000140, A5411000142, A5411000314, A5411000342, A5411000347, A5411000349, A5410000007, A5411000017, A5411000315, A5411000331, A5411000332, A5411000463, A5411000141, A5411000144, A5411000539, A5411000541, A5411000069, A5411000133, A5411000175, A5411000119, A5411000123, A5411000019, A5411000400, A5411000401, A5411000540, A5411000047, A5411000048, A5411000053, A5410000041, A5410000042, A5410000046, A5411000041, A5411000079, A5411000024, A5411000032, A5411000083, A5411000038, A5411000132, A5411000571, A5411000573, A5411000050, A5411000088, A5411000247, A5411000070, A5411000078, A5411000082, A5411000476, A5411000478, A5411000480, A5411000482, A5411000489, A5411000490, A5411000563, A5411000582, A5411000154, A5411000156, A5411000404, A5411000500, A5411000501, A5411000589, A5411000591, A5411000583, A5411000236, A5411000155, A5411000151, A5411000191, A5411000192, A5411000194, A5411000193, A5411000249, A5411000052, A5411000185, A5411000237, A5411000030, A5411000397, A5411000587, A5411000499, A5411000503, A5411000504, A5411000574, A5411000584, A5411000348, A5411000193, A5411000268, A5411000498, A5411000502, A5411000509, A5411000403, A5411000153, A5411000233, A5411000235, A5411000318, A5411000398, A5411000538, A5411000371, A5410000043, A5411000181, A5411000158, A5411000513, A5411000514, A5411000152, A5411000548, A5411000553, A5411000199, A5411000209, A5411000210, A5411000232, A5411000346, A5411000124, A5411000174, A5411000177, A5411000230, A5411000468, A5411000469, A5411000470, A5411000173, A5411000316, A5411000145, A5411000188, A5411000197, A5411000202, A5411000203, A5411000206, A5411000208, A5411000335, A5411000336, A5411000533, A5411000537, A5411000536, A5411000159, A5410000038, A5411000148, A5411000149, A5411000134, A5411000405, A5411000120, A5411000125, A5411000372, A5411000147, A5411000588, A5411000039, A5411000117, A5411000121, A5411000333, A5411000334, A5411000377, A5411000040, A5411000240, A5411000593, A5411000594, A5411000085, A5411000419, A5411000097, A5411000281, A5411000278, A5411000279, A5411000280, A5411000492, A5411000282, A5411000245, A5411000277, A5411000064, A5411000065, A5411000187, A5411000198, A5411000207, A5411000211, A5411000212, A5411000231, A5411000399, A5411000491, A5411000493. A5411000524, A5411000497, A5411000534, A5411000526, A5411000535, A5411000122, A5411000575, A5411000576, A5411000577, A5411000495, A5411000578, A5410000044, A5411000037, A5411000241, A5411000246, A5411000108, A5411000110, A5411000114, A5411000312, A5411000074, A5411000080, A5411000522, A5411000033, A5411000139, A5411000543, A5411000182, A5411000190, A5411000021, A5411000374, A5411000218, A5411000572, A5411000084, A5411000098, A5411000238, A5411000116, A5411000408, A5411000409, A5410000042, A5410000023, A5411000544, A5411000580, A5411000581, A5411000545, A5411000546, A5411000547, A5411000579, A5411000337, A5411000338, A5411000340, A5411000341, A5411000475, A5411000549, A5411000373, A5411000420, A5410000133, A5410000117, A5410000115, A5410000079, A5410000131, A5410000066, A5410000132, A5410000114, A5410000082, A5410000116, A5411000025, A5411000523, A5411000525, A5411000590, A5411000592, A5411000263, A5411000309, A5411000262, A5411000270, A5411000272, A5411000273, A5411000293, A5411000363, A5411000260, A5411000264, A5411000269, A5411000271, A5411000291, A5411000292, A5411000261, A5411000265, A5411000266, A5411000267, A5411000034, A5411000081, A5411000146, A5411000092, A5411000093, A5411000407, A5411000026, A5411000068, A5411000367, A5411000368, A5411000465, A5411000060, A5411000131, A5411000018, A5411000100, A5411000515, A5411000313, A5411000284, A5411000076, A5411000135, A5411000180, A5411000343, A5411000285, A5411000311, A5411000375, A5411000062, A5411000136, A5411000179, A5411000178, A5411000421, A5411000427, A5411000376

Distribution pattern

Worldwide Distribution - US including AL, AR, CA, CO, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OK, OR, RI, SC, TN, TX, VA, WV, WI, WY, and Internationally to Canada.